June 6, 2022

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

℅ Bryan Behn
Regulatory Affairs Director
9900 Innovation Dr.
WAUWATOSA WI 53226

Re: K220358
Trade/Device Name: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 28, 2022
Received: April 29, 2022

Dear Bryan Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.33
Silver Spring, MD 20993
www.fda.gov
K220358 - Bryan Behn Page 2

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yanna S. Kang -S For

Michael D. O’Hara, Ph.D.

Deputy Director
DHT 8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT 8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
K220358
 510(k) Summary (K220358)

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: April 28, 2022
Submitter: GE Healthcare [GE Healthcare Austria GmbH & Co OG]
Tiefenbach 15
Zipf, Austria 4871

Primary Contact Bryan Behn

Person: Regulatory Affairs Director
GE Healthcare
T:(262)247-5502
F:(414)918-8275

Secondary Contact Roland Kuntscher

Person: Regulatory Affairs Specialist
GE Healthcare Austria GmbH & Co OG
T:(+43)7682-3800-660
F:(+43)7682 3800-47
Device: Trade Voluson Expert Series
Name: Models: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Common/Usual Ultrasound system
Name:
Classification Names: Class II
Product Code: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate K201768 Voluson E10 Diagnostic Ultrasound System
Device(s):

Classification Names: Class II

Product Code: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Reference Predicate
K192159 Voluson E10/E8/E6
Device(s):
K173555 LOGIQ E10
Classification Names:
Class II
Product Codes: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

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Device Description: The systems are full-featured Track 3 ultrasound systems, primarily for
general radiology use and specialized for OB/GYN with particular
features for real-time 3D/4D acquisition. They consist of a mobile
console with keyboard control panel; color LCD/TFT touch panel,
color video display and optional image storage and printing devices.
They provide high performance ultrasound imaging and analysis and
have comprehensive networking and DICOM capability. They utilize a
variety of linear, curved linear, matrix phased array transducers
including mechanical and electronic scanning transducers, which
provide highly accurate real-time three-dimensional imaging
supporting all standard acquisition modes.
The following probes are the same as the predicate: RIC5-9-D, IC5-9-
D, RIC6-12-D, 9L-D, 11L-D, ML6-15-D, RAB6-D, C1-6-D, C2-9-D,
M5Sc-D, RM7C, eM6CG3. The following have migrated from
LOGIQ E10 6S-D and L18-18i-D (K173555). The RSP6-16-D was
previously cleared on the Voluson E10 (K192159) and has been added
back. The RIC10-D is a new probe and is substantially equivalent to
the RIC5-9-D, it is an incremental improvement in technology.

Intended Use: The device is a general purpose ultrasound system intended for use by
qualified and trained healthcare professionals. Specific clinical
applications remain the same as previously cleared:
Fetal/OB; Abdominal (including GYN, pelvic and infertility
monitoring/follicle development); Pediatric; Small Organ (breast,
testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and
pediatric); Musculo-skeletal Conventional and Superficial; Vascular;
Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color
Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded
Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography
and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD,
B/Power/ PWD, B/Elastography. The Voluson™ Expert 18, Voluson™
Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or
medical clinic.
Technology: The Voluson Expert Series (Voluson E22/20/18) employs the same
fundamental scientific technology as its predicate devices.

Determination of Comparison to Predicates

Substantial The proposed Voluson Expert 22/20/18 is substantially equivalent to
Equivalence: the predicate device with regards to intended use, imaging capabilities,
technological characteristics and safety and effectiveness.

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New Model Names and Model differences:
New model names Voluson Expert 18, Voluson Expert 20 and
Voluson Expert 22 are similar in hardware . Voluson Expert 18 is
lower version and not all probes or functions are available. Voluson
Expert 20 is mid version and product with complete configuration with
all the probes and functions of software with exception of 4D
electronically probe eM6CG3. The high-end model Voluson Expert
22 allows to drive additionally 4D electronically probe eM6CG3.

• The systems are all intended for diagnostic ultrasound imaging

and fluid flow analysis.
• The proposed Voluson Expert 22/20/18 and predicate Voluson
E10 systems have the same clinical intended use.
• The proposed Voluson Expert 22/20/18 and predicate Voluson
E10 systems have the same imaging modes.
• The proposed Voluson Expert 22/20/18 and predicate Voluson
E10 system transducers are equivalent. Four new transducers
RSP6-16-D, L8-18i-D, 6S-D and RIC10-D were added and
three transducers removed to the proposed system.
• There is no change to the system indications for use.
• The systems are manufactured with materials which have
been evaluated and found to be safe for the intended use
of the device.
• The systems have acoustic power levels which are below
the applicable FDA limits.

• The proposed Voluson Expert Series 22/20/18 and predicate

Voluson E10 system have similar capability in terms of
performing measurements, capturing digital images, reviewing
and reporting studies.
• The proposed Voluson Expert Series 22/20/18 and predicate
systems have been designed in compliance with approved
electrical and physical safety standards.

• There proposed Voluson Expert Series 22/20/18 and predicate

Voluson E10 system Software Features are equivalent. Some
minor improvements to the existing Software features have
been implemented into the proposed system.

• The proposed Voluson Expert Series 22/20/18 adds additional

AI software features SonoPelvicFloor and SonoLyst/
Sonolyst Live (workflow improvement) to the system.

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 • The proposed Voluson Expert Series 22/20/18 adds additional
software features Shadow Reduction , Adapt and Sono FHR
(Performance improvement) to the system.

• The proposed Voluson Expert Series 22/20/18 migrated from

(K192159) the following software features Elastography,
Shear Wave Elastography , CW Doppler Mode and
Acquisition mode Contrast.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility,
cleaning and disinfection effectiveness as well as thermal, electrical,
electromagnetic, and mechanical safety, and has been found to conform
to applicable medical device safety standards. The Voluson Expert
Series 22/20/18 and its applications comply with voluntary standards:
• AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part
1: General Requirements for Safety, 2005/(R)2012 And
A1:2012
• IEC60601-1-2 Medical Electrical Equipment – Part 1-2:
General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility Requirements and Tests, 2014
• IEC60601-2-37, Medical Electrical Equipment – Part 2-37:
Particular Requirements for the Safety of Ultrasonic Medical
Diagnostic and Monitoring Equipment, 2015
• ISO10993-1, Biological Evaluation of Medical Devices- Part 1:
Evaluation and Testing- Third Edition, 2009
• ISO14971, Application of risk management to medical devices:
Third edition 2019
• NEMA PS 3.1 - 3.20 (2022a), Digital Imaging and
Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures are applied to the

development of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)

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 • Safety testing (Verification)
• Final Acceptance Testing (Validation)

Transducer materials and other patient contact materials are

biocompatible.

AI Summary of Testing

SonoPelvic Floor:
Summary test statistics or other test results including acceptance
criteria or other information supporting the appropriateness of the
characterized performance.
• Tested on datasets marked as Good in Image Quality
assessment, the success rate of each AI component of the
feature (MHD plane alignment, LH contour and measurements)
is expected to be 70% or higher. On datasets that are marked as
challenging in image quality measure the success rate of each
AI component of the feature should be 60% or higher.
• The number of individual patients images were collected from:
70+
• The number of samples, if different from above, and the
relationship between the two: 110 3D/4D Volumes
Demographic distribution:
• Gender: Female
• Age: Reproductive age, specific age not collected
• Ethnicity/Country; Europe, Asia and South Africa
Information about clinical subgroups and confounders present in the
dataset:
• During testing, a differentiation is made between good IQ
(Image Quality) and challenging IQ datasets.
Information about equipment and protocols used to collect images:
• Mix of data from across six different probe models and five
different Console variants. The data collection protocol was
standardized across all data collection sites.
Information about how the reference standard was derived from the
dataset (i.e. the “truthing” process)
• For the testing process, the results are generated by the AI
software and the same are verified as Pass or Fail by a certified
sonographer/Clinician. The results are then aggregated to yield
an accuracy metric for the AI algorithm.
Description of how independence of test data from training data was
ensured.

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 • The volumes used for test/validation purpose is completely
distinct from the ones used during training process and there is
no overlap between the two.

SonoLyst:
Summary test statistics or other test results including acceptance
criteria or other information supporting the appropriateness of the
characterized performance
• For SonoLystIR the sorting accuracy is higher than 80% on a
test data set containing 40000+ images. For SonoLystX the
grading accuracy is higher than 80% on a test data set
containing 9500+ images. For SonoLystLive the accuracy is
higher than 80% on a test data set containing 5500+ images.
• The number of individual patients images were collected from:
5000+ exams
• The number of samples, if different from above, and the
relationship between the two: SonoLyst was tested on 40000+
images derived from the collected exams. The exams contain
multiple standard views of the fetal anatomy and cine loops.
Demographic distribution
• Gender: Female
• Age: Gestational Age of fetuses: 18-24 weeks
• Ethnicity/Country: Exams from United Kingdom, Austria,
India, USA
Information about clinical subgroups and confounders present in the
dataset:
• During testing, a differentiation was made between
retrospective and prospective data collection from GE and non-
GE scanners, evaluating the generalization performance.
Information about equipment and protocols used to collect images.
• Mix of data from across five different console variants, 4
Voluson GE, 1 non-GE. Mix of data from retrospective data
collection in clinical practice and prospective data collection.
Information about how the reference standard was derived from the
dataset (i.e. the “truthing” process):
1. The images were curated (sorted and graded) by a single
Sonographer
2. The images were sorted and graded by SonoLyst.
This process resulted in some images being reclassified
during sorting.
3. Where they differed from the ground truth, the sorted

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 images from step 2 were reviewed by a 5-sonographer
review panel, in order to determine the sorting accuracy of
the system. The sorting process resulted in some images
being reclassified based upon the majority view of the
panel.
4. Where they differed from the ground truth, the graded
images from step 1 were reviewed by a 5-sonographer
review panel, in order to determine the grading accuracy of
the system.
Description of how independence of test data from training data was
ensured:
• The exams used for test/training validation purpose are
separated from the ones used during training process and there
is no overlap between the two.

FetalHS:
Summary test statistics or other test results including acceptance
criteria or other information supporting the appropriateness of the
characterized performance.
• The success rate of the 4CH view and 3VT view suggestion
within cines is expected to be 70% or higher. The success rate
of the suggested heart angle measurement is expected to be
80% or higher.
• The number of individual patients images were collected from:
250+ patients
• The number of samples, if different from above, and the
relationship between the two: 400+ cines
Demographic distribution
• Gender: Female
• Age: Gestational age 18-25 weeks
• Ethnicity/Country : USA, India, Japan, Germany, Austria
Information about clinical subgroups and confounders present in the
dataset.
• Cines were grouped into the sub-groups 4CH view present / not
present, 3VT view present / not present
Information about equipment and protocols used to collect images.
• Mix of data from across six different probe models and three
different console variants. The data collection protocol was
standardized across all data collection sites.
Information about how the reference standard was derived from the
dataset (i.e. the “truthing” process).
• For the testing process, the results are generated by the AI

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 software and the same are verified as Pass or Fail by certified
sonographers/clinicians. The results are then aggregated to yield
an accuracy metric for the AI algorithm.
Description of how independence of test data from training data was
ensured.
• The data sets used for test/validation purpose are completely
distinct from the ones used during training process and there is
no overlap between the two.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson Expert Series
22/20/18 did not require clinical studies to support substantial
equivalence.

Conclusion: GE Healthcare considers the Voluson Expert Series 22/20/18 to be as

safe, as effective, and performance is substantially equivalent to the
predicate device(s).