The SuperSonic Imagine® SuperSonic® Hepa Vi™ ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric.

Modes of operation include: B-mode ID : Panoramic Imaging; Spatial Compounding], M-mode. Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); Shear Wave dispersion Viscosity (Vi PLUS); Combination Modes [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/ SWE); (B/M-mode/Color flow)].

In addition, the SuperSonic® HepaVu™ ultrasound diagnostic systems and associated transducers are intended for:

· Measurements of abdominal anatomical structures,
· Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
· Measurements of brightness ratio between liver and kidney,
· Visualization of abdominal vascularization, microvascularization and perfusion,
Quantification of abdominal vascularization and perfusion

The shear wave speed, ultrasound attenuation coefficient, backscattering coefficient, viscosity and stiffness measurements, the brightness ratio, the visualization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.

Device Description

The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic hepatology purpose ultrasound imaging studies.

The system contains a scan converter and can be coupled to a variety of linear and curved trransducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.

The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.

The principle software change with respect to the MACH software version is related to the following feature:

-Backscattering coefficient (BSc): The backscattering coefficient characterizes the ability of a tissue to reflect incoming ultrasound wave back to the direction from which they came. Local measurement of the backscattering is expressed in db/cm.str over a range of values (from -38 db/cm.str to -24 db/cm.str).
Bsc PLUS mode is available for all Abdominal presets on C6-1X and C9-2X transducers.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the SuperSonic® HepaVu™ ultrasound diagnostic system, outlining its indications for use, technological characteristics compared to a predicate device, and non-clinical testing for substantial equivalence. It explicitly states that "No clinical tests have been performed on SuperSonic® HepaVu™ System." Therefore, the requested information cannot be extracted from this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2024

SuperSonic Imagine % Charlotte Turc Official Correspondent Zac de l'Enfant 135 Rue Émilien Gautier Aix-En-Provence, 13290 FRANCE

Re: K242223

Trade/Device Name: SuperSonic® HepaVu™ Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 29, 2024 Received: September 4, 2024

Dear Charlotte Turc:

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 (the 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 available 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

{2}------------------------------------------------

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Marjan Nabili -S for

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K242223

Device Name SuperSonic® HepaVu™

Indications for Use (Describe)

In addition, the SuperSonic® HepaVu™ ultrasound diagnostic systems and associated transducers are intended for:

· Measurements of abdominal anatomical structures,
· Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
· Measurements of brightness ratio between liver and kidney,
· Visualization of abdominal vascularization, microvascularization and perfusion,
Quantification of abdominal vascularization and perfusion

1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for "SuperSonic Imagine". The word "SuperSonic" is in a light blue color, while the word "imagine" is in a dark gray color. There is a trademark symbol to the bottom right of the word "imagine".

510(K) Summary

K242223

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.

1. Submitter's name, address, telephone number, contact person
  SuperSonic Imagine, S.A. Zac de l'Enfant 135 Rue Émilien Gautier 13290 Aix-En-Provence FRANCE Telephone: +33(4) 42 99 24 24 E-mail : contactsFR@supersonicimagine.com

Primary Contact: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: +33(4) 42 99 24 24

Date: September-19-2024

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
  Common/Usual Name: Ultrasound Diagnostic System with Accessories Proprietary Name: SuperSonic® HepaVu™ Classification: Class II

Classification Name:	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

1. Substantially Equivalent/Predicate Device
  AIXPLORER® / SUPERSONIC® MACH range Ultrasound Imaging System (K222191), cleared on 10/28/2022

{6}------------------------------------------------

4. Description of Device

The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic hepatology purpose ultrasound imaging studies.

The principle software change with respect to the MACH software version is related to the following feature:

-Backscattering coefficient (BSc): The backscattering coefficient characterizes the ability of a tissue to reflect incoming ultrasound wave back to the direction from which they came. Local measurement of the backscattering is expressed in db/cm.str over a range of values (from -38 db/cm.str to -24 db/cm.str).
Bsc PLUS mode is available for all Abdominal presets on C6-1X and C9-2X transducers.

5. Indications for Use

The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric.

Modes of operation include: B-mode [2D ; Panoramic Imaging; Spatial Compounding], M-mode, Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); ShearWave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [[8/Color Flow]; (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/SWE); (B/Mmode/Color flow)].

In addition, the SuperSonic® SuperSonic® HepaVu™ range ultrasound diagnostic systems and associated transducers are intended for:

Measurements of abdominal anatomical structures,
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
. Measurements of brightness ratio between liver and kidney,
Visualization of abdominal vascularization, microvascularization and perfusion,
Quantification of abdominal vascularization and perfusion

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Supersonic Imagine. The word "SUPERSONIC" is written in light blue, with the word "imagine" written in dark gray below it. A trademark symbol is located to the bottom right of the word "imagine".

1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis.

6. Summary of Technological Characteristics – New Device compared to Predicates

	NEW DEVICESuperSonic® HepaVu™	PREDICATE DEVICEAIXPLORER® MACH / SUPERSONIC® MACH range	Discussion
510(k) Number	Unknown	K222191	-
ClassificationName	Ultrasonic Pulsed Doppler Imaging System(892.1550)Ultrasonic Pulsed Echo Imaging System(892.1560)Diagnostic Ultrasound Transducer(892.1570)	Ultrasonic Pulsed Doppler Imaging System(892.1550)Ultrasonic Pulsed Echo Imaging System (892.1560)Diagnostic Ultrasound Transducer (892.1570)	Identical
Class	Class II	Class II	Identical
Product Code	IYN, IYO, ITX	IYN, IYO, ITX	Identical
Indications for use	The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound diagnostic system andtransducers are intended for general purpose pulse echo ultrasound imaging, softtissue viscoelasticity imaging, doppler fluidflow analysis of the human body.The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is indicated foruse in the following applications, for imagingand measurement of anatomical structures:Abdominal for Adult and Pediatric.Modes of operation include: B-mode [2D ;Panoramic Imaging; Spatial Compounding],M-mode, Doppler [Pulsed Wave (PW); Colorand Power Doppler (Color Flow Imaging),Color Doppler (Angio PL.U.S)], TissueHarmonic Imaging, Contrast EnhancedUltrasound Imaging (CEUS); ShearWaveElastography (SWE); ShearWave dispersionViscosity (Vi PLUS); Combination Modes[(B/Color Flow); (B/SWE), (B/PW),(B/PW/Color Flow); (B/ M-mode); (B/Colorflow/SWE); (B/M-mode/Color flow)].In addition, the SuperSonic Imagine®SuperSonic® HepaVu™ range ultrasounddiagnostic systems and associatedtransducers are intended for:Measurements of abdominal anatomicalstructures,Measurements of broad band shear wavespeed, and tissue stiffness in internalstructures of the liver and the spleen	The SuperSonic Imagine® SuperSonic® MACHrange ultrasound diagnostic systems andtransducers are intended for general purposepulse echo ultrasound imaging, soft tissueviscoelasticity imaging, doppler fluid flow analysisof the human body.The SuperSonic Imagine® SuperSonic® MACHRange ultrasound systems are indicated for use inthe following applications, for imaging andmeasurement of anatomical structures:Abdominal, Small Organs, Musculoskeletal,Superficial Musculoskeletal, Vascular, PeripheralVascular, OB-GYN, Pelvic, Pediatric, Urology,Trans-rectal, Transvaginal and Neonatal/AdultCephalic, Non-invasive Cardiac.Modes of operation include: B-mode [2D ; 3D ;Panoramic Imaging; Spatial Compounding], M-mode, Doppler [Continuous Wave (CW); PulsedWave (PW); Color and Power Doppler (Color FlowImaging), Color Doppler (Angio PL.U.S)], StrainElastography, Tissue Harmonic Imaging, ContrastEnhanced Ultrasound Imaging (CEUS); ShearWaveElastography (SWE); ShearWave dispersionViscosity (Vi PLUS); Combination Modes [ (B/ColorFlow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/M-mode); (B/Color flow/SWE); (B/CW) ; (B/M-mode/Color flow); (B/Strain Elastography/SWE)].In addition, the SuperSonic Imagine® SuperSonic®MACH Range ultrasound diagnostic systems andassociated transducers are intended for:Measurements of abdominal anatomicalstructures	Identical: adapted toliver applications
NEW DEVICE	PREDICATE DEVICE	Discussion
SuperSonic® HepaVu™	AIXPLORER® MACH / SUPERSONIC® MACH range
Measurements of brightness ratio betweenliver and kidney,Visualization of abdominal vascularization,microvascularization and perfusion,Quantification of abdominal vascularizationand perfusionThe shear wave speed, ultrasoundattenuation coefficient, backscatteringcoefficient, viscosity and stiffnessmeasurements, the brightness ratio, thevisualization of vascularization,microvascularization and perfusion, the	Measurements of broad band shear wave speed,and tissue stiffness in internal structures of theliver and the spleen,Measurements of brightness ratio between liverand kidney,Visualization of abdominal vascularization,microvascularization and perfusion,Quantification of abdominal vascularization andperfusionThe shear wave speed, beam attenuation, viscosityand stiffness measurements, the brightness ratio,the visualization of vascularization,microvascularization and perfusion, thequantification of vascularization and perfusionmay be used as an aid to clinical management ofadult and pediatric patients with liver disease.
quantification of vascularization andperfusion may be used as an aid to clinicalmanagement of adult and pediatric patientswith liver disease.	Furthermore, the SuperSonic® MACH ultrasounddiagnostic systems and associated transducers areintended for:Measurement of breast anatomical structuresMeasurements of broad band shear waves speedand tissue stiffness in internal structures of thebreastVisualization of breast structures and micro-vascularizationVisualization of breast masses morphology usingshearwave elastography and mmicro-vascularization 2D mapping.The shear waves speed and stiffnessmeasurements may be used as an aid tomanagement of women patients with breastmasses, as shearwave elastography in conjunctionwith 2D gray scale imaging and vascularizationprovides added information to better characterizebreast masses and improved the diagnosticaccuracy of ultrasound.This device is intended for use by, or by the orderof, and under the supervision of a licensedphysician qualified to use or direct the use of thedevice. This device is intended for use in hospitalenvironment or physician's office This systemshould only be used by trained Health CareProfessionals (HCP) who are knowledgeable aboutthe risk of excessive acoustic energy in the body,particularly in the case where a great amount offluid is present in the scanning area.1 Information delivered by the device must be used by a licensedphysician qualified to establish a diagnosis.
GeneralDescription	General purpose, mobile, softwarecontrolled diagnostic ultrasound system. Toacquire ultrasound data and to display thedata in various modes of operation.	General purpose, mobile, software controlleddiagnostic ultrasound system. To acquireultrasound data and to display the data in variousmodes of operation.	Identical
	NEW DEVICE	PREDICATE DEVICE	Discussion
	SuperSonic® HepaVu™	AIXPLORER® MACH / SUPERSONIC® MACH range
	Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc...).	Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc...).	Identical
	Abdominal (liver, kidney, spleen)	Abdominal (liver, kidney, spleen)	Identical
	-	Small organs (Breast, Thyroid, Testicle, etc)	N/A
	-	Musculoskeletal	N/A
	-	Fetal	N/A
	-	GYN	N/A
	-	Cardiac (non invasive)	N/A
	-	Adult and neonatal cephalic	N/A
ClinicalApplications	Pediatric	Pediatric	Identical use for pediatric(Abdominal)
	-	Urology	N/A
	-	Vascular	N/A
	-	Peripheral vascular	N/A
	-	Trans-rectal	N/A
	-	Trans-vaginal	N/A
	Imaging modes
	B-Mode (Harmonic, Fundamental)	B-Mode (Harmonic, Fundamental)	Identical
	M-Mode	M-Mode	Identical
Conventional	PW	PW	Identical
	-	CW	N/A
	Color Doppler	Color Doppler	Identical
	Amplitude Doppler	Amplitude Doppler	Identical
	Microvascular (Angio PL.U.S)	Microvascular (Angio PL.U.S)	Identical
	Spatial compounding, Panoramic	Spatial compounding, Panoramic	Identical
	Contrast	Contrast	Identical
	Combination of modes	Combination of modes	Identical
Other	ShearWave Elastography	ShearWave Elastography	Identical
	-	Strain Elastography	N/A
	Attenuation (Att PLUS)	Attenuation (Att PLUS)	Identical
	Sound Speed Plane wave (SSp PLUS)	Sound Speed Plane wave (SSp PLUS)	Identical
	Backscattering (Bsc plus)	-	New
	Design
	NEW DEVICE	PREDICATE DEVICE	Discussion
	SuperSonic® HepaVu™	AIXPLORER® MACH / SUPERSONIC® MACH range
Cart	Mobile cart based product with control paneland monitor	Mobile cart based product with control panel andmonitor	Identical
Controls	Typical ultrasound imaging controls (gain,depth mode select...)	Typical ultrasound imaging controls (gain, depthmode select...)	Identical
Biopsy guides	Available	Available	Identical
Track	Track 3 (Acoustic Output Display)	Track 3 (Acoustic Output Display)	Identical
PatientContactMaterials	Yes, per ISO 10993-1 :2018	Yes, per ISO 10993-1 :2018	Identical
AcousticOutputwithinFDAguidelines	Yes, as per NEMA UD-3	Yes, as per NEMA UD-3	Identical
General Safety	Conform to IEC60601-1:2020, 60601-1-2:2020, 60601-2-37:2015	Conform to IEC60601-1:2020, 60601-1-2:2020,60601-2-37:2015	Identical
Accessoires
	L10-2C6-1X	L18-5L10-2C6-1X	Identicalwithreduction of thenumber of probes inaccordance with the
	C9-2X	C9-2X	HepaVu™ scope.
Probes		LV16-5
		LH20-6
		P5-1X
		E12-3
		MC12-3
Cleaning&Disinfectants	Yes	Yes	Identical
Probe sheaths	C6-1X & C9-2X probes610-637610-1000610-542610-362L10-2 probe	C6-1X & C9-2X probes610-637610-1000610-542610-362L10-2 probe	Identical withreduction of thenumber of probes inaccordance with theHepaVu™ scope.
	610-323610-001	610-323610-001
Gel	Yes	Yes	Identical
Biopsy Guides	C6-1X probe672-002 by Clvco610-901 by ClvcoC9-2X probe653-005 by Clvco	L18-5 probe672-001 by ClvcoC6-1X probe672-002 by Clvco610-901 by ClvcoE12-3 probe	Identicalwithreductionofthenumber of probes inaccordance with theHepaVu™ scope.
		657-014 by Clvco610-666 by Clvco610-1275 by Clvco
	NEW DEVICESuperSonic® HepaVu™	PREDICATE DEVICEAIXPLORER® MACH / SUPERSONIC® MACH range	Discussion
Gel warmer	Yes	Yes	Identical
Footswitch	Yes	Yes	Identical
DICOM	Yes	Yes	Identical
Barcode Scanner	Yes	Yes	Identical
ECG	Yes	Yes	Identical

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for "Supersonic Imagine". The word "Supersonic" is in a light blue font, while the word "Imagine" is in a dark gray font. The "TM" symbol is located to the bottom right of the word "Imagine".

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for "Supersonic Imagine". The word "SUPERSONIC" is in light blue, and the word "imagine" is in dark gray. There is a trademark symbol to the right of the word "imagine".

{10}------------------------------------------------

SUPERSONIC

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for "SuperSonic Imagine". The word "SUPERSONIC" is in a light blue sans-serif font, stacked above the word "imagine" which is in a dark gray sans-serif font. The letters "TM" are in the bottom right corner of the logo.

1. A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
  Non-clinical testing has been conducted per the following standards, as per the below table :

Reference Standard	Tests Performed
IEC 60601-1 Ed.3.1	All applicable electrical, basic safety and essentialperformance tests.
IEC 60601-1-2 Ed.4	All applicable testing pertaining to electromagneticcompatibility.
IEC 60601-2-37 Ed.2.1	All applicable testing pertaining to the particularrequirements for the safety of ultrasonic medicaldiagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstrate compliancewith the "Accoustic Output Measurement Standard forDiagnostic Ultrasound Equipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstrate compliancewith the "Standard For Real Time Display Of ThermalAnd Mechanical Acoustic Output Indices On DiagnosticUltrasound Equipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriate devicecategory.

The above testing confirmed that the SuperSonic® HepaVu™ System performs in accordance with the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s).

1. A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
  Not applicable. No clinical tests have been performed on SuperSonic® HepaVu™ System.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image contains the logo for "Supersonic Imagine". The word "SUPERSONIC" is in a light blue sans-serif font, stacked above the word "imagine" which is in a dark gray sans-serif font. To the right of "imagine" is the trademark symbol.

9. Conclusion

The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate device.

Fin du Document / End of Document

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.