Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems by Supersonic Imagine

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems 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 AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.

Device Description

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart-based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear and phased array transducers 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), Mmode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography and Strain Elastography.

AI/ML Overview

This document describes the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and their accessories. The devices are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, and Doppler fluid flow analysis of the human body. The submission is for a 510(k) premarket notification, seeking substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device and its transducers are based on demonstrating substantial equivalence to the predicate device (AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems, K191007). The reported device performance is that the new device is identical or has additions/improvements while maintaining the safety and effectiveness of the predicate.

Feature/Criterion	Predicate Device (K191007)	New Device (K202455)	Performance
Classification Name	Ultrasonic Pulsed Doppler Imaging System (892.1550), Ultrasonic Pulsed Echo Imaging System (892.1560), Diagnostic Ultrasound Transducer (892.1570)	Identical	The new devices have identical classification names, indicating they fall under the same regulatory categories.
Class	Class II	Identical	The new devices maintain the same Class II classification.
Intended Use	Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body	Identical	The intended use statement for diagnostic imaging, elasticity imaging, and fluid flow analysis is identical, confirming the new devices perform the same core functions.
General Description	General purpose, mobile, software controlled diagnostic ultrasound system. Acquires and displays ultrasound data in various modes. Consists of system console and transducer.	Identical	The general description of the system's physical characteristics and core functionality is identical.
Clinical Applications	Abdominal, Small organs, Musculoskeletal, Fetal, GYN, Cardiac (non-invasive), Adult and neonatal cephalic, Pediatric, Urology, Vascular, Peripheral vascular, Trans-rectal, Trans-vaginal.	Identical (with new indications for specific transducers - see details below)	The core clinical applications are identical. However, some transducers exhibit "new indications" (marked with 'N' in the tables for transducers L10-2, L18-5, C9-2X, C6-1X, E12-3, MC12-3, LV16-5, LH20-6, P5-1X), broadening the scope for specific modalities on those transducers.
Imaging Modes (Conventional)	B-Mode (Harmonic, Fundamental), M-Mode, PW, CW, Color Doppler, Amplitude Doppler, Microvascular (Angio PL.U.S)	Identical	All conventional imaging modes are identical.
Other Imaging Features	Spatial compounding, Panoramic, Contrast	Identical (Addition of Contrast availability on clinical applications)	The general features are identical, with the new device explicitly stating the addition of Contrast availability on clinical applications.
Combination of Modes	Available	Identical	The ability to combine modes is identical.
Elastography	ShearWave Elastography, Strain Elastography	Identical	Both ShearWave and Strain Elastography functions are identical.
Design (Cart, Controls)	Mobile cart based product with control panel and monitor; Typical ultrasound imaging controls (gain, depth mode select...).	Identical	The physical design regarding the cart and user controls is identical.
Biopsy Guide	Available	Identical	Biopsy guidance functionality is identical.
Acoustic Output	Yes, as per NEMA UD-3	Identical	The acoustic output remains within FDA guidelines as per NEMA UD-3.
Patient Contact Materials	Yes, per ISO 10993-1	Identical	Patient contact materials comply with ISO 10993-1.
Image Review, Measurement, Calculation, Report	Yes	Identical	Features for image review, measurement, calculation, and reporting are identical.
General Safety	Conforms to IEC60601-1, 60601-1-2, 60601-2-37	Identical	Compliance with general safety standards is identical.
Labeling	Conforms to 21 CFR Part 801	Identical	Labeling complies with 21 CFR Part 801.

2. Sample Size Used for the Test Set and Data Provenance

The provided document is a 510(k) summary for an ultrasound diagnostic system. It explicitly states in section 8: "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." This indicates that no clinical tests were performed or relied upon for this submission. Therefore, there is no test set sample size and no data provenance in terms of patient data from clinical studies for this specific submission to evaluate the AI's performance.

The submission focuses on non-clinical testing and comparison to a predicate device. The "new indications" for transducers are for established ultrasound modalities (e.g., CEUS, Strain Elastography, new quantification methods), not a novel AI-driven diagnostic.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical studies with patient data were conducted or relied upon for this 510(k) submission, there were no experts used to establish ground truth for a test set. The evaluation was based on non-clinical engineering and performance testing to demonstrate substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Not applicable" for clinical tests (Section 8). This type of study would involve human readers and their performance with and without AI assistance, which is outside the scope of this non-clinical submission for substantial equivalence based on technical specifications and functional equivalence to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe any specific "standalone" AI algorithm performance studies. While the devices include features like "ShearWave™ Elastography" and "Strain Elastography" which rely on sophisticated algorithms for tissue property assessment, these features were previously cleared on the predicate device (K191007) and are stated to be "Identical." The submission emphasizes functional equivalence and safety rather than novel AI performance claim. The new features for the AIXPLORER® MACH / SUPERSONIC MACH systems are "Vi PLUS" and "Att PLUS & SSp PLUS" for specific transducers (L10-2, C6-1X, C9-2X). These are described as measurements related to vascularization, microvascularization, perfusion, and attenuation/shear wave speed, which may involve advanced processing, but their standalone performance is not detailed in the context of a dedicated performance study against ground truth.

7. The Type of Ground Truth Used

Given the absence of clinical studies, there was no ground truth derived from expert consensus, pathology, or outcomes data in the context of this 510(k) submission. The "ground truth" for the non-clinical testing was defined by established engineering and performance standards (e.g., acoustic output measurements against NEMA standards, electrical safety against IEC standards) and comparison to the predicate device's established performance.

8. The Sample Size for the Training Set

Since no AI-specific clinical performance study for a novel algorithm was described, there is no information provided regarding a training set sample size. The submission is focused on demonstrating that the new device's technical specifications and functionality are substantially equivalent to a previously cleared predicate device.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for a novel AI algorithm's clinical performance, this information is not applicable and not provided in the document.

Summary

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December 29, 2020

SuperSonic Imagine % Jacques Souquet Chief Innovation Officer Les Jardins de la Duranne - Bât. E&F 510. rue René Descartes 13857 Aix-en-Provence Cedex FRANCE

Re: K202455

Trade/Device Name: AIXPLORER® MACH 20, AIXPLORER® MACH 30, SUPERSONIC MACH40, SUPERSONIC MACH30 & SUPERSONIC MACH20 Ultrasound Diagnostic Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 12, 2020 Received: December 18, 2020

Dear Jacques Souquet:

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.

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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 803) for 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-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 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-device-safety/medical-device-reportingmdr-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/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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202455

Device Name

AIXPLORER® MACH 20, AIXPLORER® MACH 30, SUPERSONIC MACH40, SUPERSONIC MACH30 & SUPERSONIC MACH20 Ultrasound Diagnostic Systems

Indications for Use (Describe)

In addition, the SuperSonic Imagine AIXPLORER® MACH 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 supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.

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)

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Device Name: AIXPLORER® MACH 30 (SSIP95030) , AIXPLORER® MACH 20 (SSIP95020), SUPERSONIC MACH30 (SSIP95030-HOLX), SUPERSONIC MACH20 (SSIP95020-HOLX) & SUPERSONIC MACH40 (SSIP95040) Ultrasound Diagnostic Systems

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined (Specify)	Other* (Specify)
Ophthalmic	Ophthalmic			P		P		P : 5, 6, 10
Fetal Imaging &Other	Fetal	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 11,13,14, 15, 16 - N: 21,22
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P		P	P : 1, 3, 4	P: 5, 6, 8, 9
	Intra-operative (Specify) vascular,abdominal, small organs	P		P		P	P : 1, 3, 4	P: 5, 6, 8, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 11, 13, 15,16 - N: 14, 18, 19, 21, 20
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P		P	P : 1, 2, 3, 4,12	P: 5, 6, 7, 8, 9, 10, 14, 15, 18,19, 20, 21N : 13
	Neonatal Cephalic	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 9
	Adult Cephalic	P		P		P	P : 1, 3, 4	P : 5, 6
	Trans-rectal	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8N : 13
	Trans-vaginal	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 11N : 13
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 14, 15,19,20N : 13
	Musculo-skeletal (Superficial)	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 14, 15,19,20N : 13
	Intravascular
	GYN	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8 11, 14N : 13
	Pelvic	P	P	P		P	P : 1, 2, 3, 4	P: 5, 6, 7, 8,11, 14N : 13
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P : 1, 3, 4, 11, 17,18	P : 5
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P		P	P : 1, 3, 4	P : 5, 6, 8, 9, 10, 15N : 13
Vessel	Other (Specify)	P		P		P	P : 1, 3, 4	P : 5, 6, 8, 9, 10, 15N : 13

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography

9: Panoramic Imaging

8: Imaging Guidance for Biopsies

2: Combined modes include: B+ ShearWave™ Elastography

4: Combined modes include: B+ Pulsed Wave + Color Flow

10: 3D Imaging

10: 3D Imaging
11: Combined modes include: B+ M mode

TM Elastography 12: Combined modes include: B Mode + Color flow + Shearwave

Combined modes in
Enhancement | UltraSound

Enhancement Ultrasound
13: CEUS (Contrast)

Enhancement UltraSound)
13: CEUS (Contrast)
14: Angio PL.U.S (Color Doppler improvement) 15: Needle
14: Angio PL.U.S (Color Doppler improvement) 15: Needle
16: Brightnes

PL.U.S
10-B-14

17: Combined mode include: B+ Continuous Wave 18: Combined mode

include: B+ M mode + Color flow 19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS
22: Att PLUS & SSp PLUS

Combined mode: B Mode + Strain + SWE 21.
AU-DIUC & CO-DIUC

22: Att PLUS & SSp PLUS

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Device Name: L10-2 transducer (linear transducer, SSIP95103)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS

22: Att PLUS & SSp PLUS

Clinical Application Mode of Operation в M |PWD|CWD General Specific Color Combined Other* (Specify) (Track 1 Only) (Tracks 1 & 3) Doppler (Specify) Ophthalmic Ophthalmic Fetal Fetal Imaging & Other P Abdominal (including urolology): Liver, P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 13,14, 15, Kidney, Spleen ... 16 - N: 21,22 Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric P P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9,14, 15, 16, 21, 22 N : 13 Small Organ (for example Breast, Thyroid, P P P P: 1, 2, 3, 4, P: 5, 6, 7, 8, 9, 14, 15,20, Testicle, Prostate, penis, etc ... ) 21, 22 12 N : 13 P P P Neonatal Cephalic N, 1, 2, 3, 4 N, 5, 6, 7, 9 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) P P P Musculo-skeletal (Conventional) P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 14,15,20 N : 13 P Musculo-skeletal (Superficial) P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 14, 15,20 N : 13 Intravascular GYN Pelvic Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel P P P P: 1, 3, 4 P: 5, 6, 8, 9, 15 N : 13 P Other (Specify) P P P: 5, 6, 8, 9, 15 Vessel P: 1, 3, 4 N : 13

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510(k) Number (if known):

Device Name: C6-1X transducer (curved array transducer, SSIP95101)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
	Abdominal (including urolology), Liver,Kidney, Spleen.	P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8, 9, 13, 14, 16,21, 22
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13, 14, 16,21, 22
	Small Organ (Breast, Thyroid, Testicle,Prostate, penis, etc...)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8N: 13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8,11,14N: 13
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 11,14N: 13
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8N: 13
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8N: 13
Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)		B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal		P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
	Abdominal (including urolology): Liver, Kidney,Spleen...		P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)		P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8N : 13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8N : 13
	Trans-vaginal		P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8N : 13
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN		P	P	P	P	P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8N : 13
	Pelvic		P	P	P	P	P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8N : 13
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)		P		P		P	P: 1, 3, 4	P: 5, 6, 8N : 13

N = new indication; P = Previously cleared by FDA (K191007)

Additional Comments:

1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S
16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS

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510(k) Number (if known):

Device Name: E12-3 transducer (endocavitary transducer, SSIP95102)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS

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

510(k) Number (if known):

Device Name: LV16-5 transducer (motorized linear transducer, SSIP95108)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal (including urolology):Liver, Kidney, Spleen...	P		P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P			P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	P	P	P			P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P			P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Musculo-skeletal (Superficial)	P	P	P			P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P			P: 1, 3, 4	P: 5, 6, 8, 9, 10
	Other (Specify)

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

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

510(k) Number (if known):

Device Name: MC12-3 transducer (micro-curved transducer, SSIP95106)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P			P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Neonatal Cephalic	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P		P	P: 1,3,4,11	P: 5, 6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9
	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

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

510(k) Number (if known):

Device Name: P5-1X transducer (Phased Array transducer, SSIP95107)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P	P	P	P: 1, 3, 4, 11,17	P: 5, 6, 16
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P		P		P: 1, 3, 4	P: 5, 6
	Neonatal Cephalic
	Adult Cephalic	P	P		P		P: 1, 3, 4	P: 5, 6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P : 1, 3, 4, 11,17, 18	P: 5, 6
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P: 1, 3, 4, 17	P: 5, 6
	Other (Specify)	P	P	P	P	P	P: 1, 3, 4, 17	P: 5, 6

N = new indication; P = Previously cleared by FDA (K191007)

1: Combined modes include: B+ Color Flow

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging 6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

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

510(k) Number (if known):

Device Name: LH20-6 transducer (linear transducer, SSIP95104)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...
	Intra-operative (Specify) Vascular,abdominal, small organs	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Musculo-skeletal (Superficial)	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15
	Other (Specify)	P	P	P		P	P: 1, 3, 4	P: 5, 6, 9, 15

N = new indication; P = Previously cleared by FDA (K191007)

2: Combined modes include: B+ ShearWave™ Elastography

4: Combined modes include: B+ Pulsed Wave + Color Flow

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

9: Panoramic Imaging

10: 3D Imaging

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

11: Combined modes include: B+ M mode

Angio P.L.U.S (Color Doppler Im
5: Needle P.L.U.S

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

510(k) Number (if known):

Device Name: L18-5 transducer Linear Array transducer, SSIP95100)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal (including urology):Liver, Kidney, Spleen...	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P: 1, 2, 3, 4, 12	P: 5, 6, 7, 8, 9, 14 – N: 19,20
	Neonatal Cephalic	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9,14, 15 – N:19, 20
	Musculo-skeletal (Superficial)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9,14, 15 – N:19, 20
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9, 15
	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9, 15

N = new indication; P = Previously cleared by FDA (K180572)

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

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

510(k) Number (if known):

Device Name: C9-2X transducer Curved Array transducer, SSIP95105) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
Other	Abdominal (including urology):Liver, Kidney, Spleen...	P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8, 9, 13, 14, 16 -N: 21, 22
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 13, 16 - N: 21,22
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8N : 13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14N : 13
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14N : 13
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8N : 13
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8N : 13

N = new indication; P = Previously cleared by FDA (K180572)

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
12: Combined modes include: B Mode + Color flow + Shearwave™Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS

{13}------------------------------------------------

510(k) Summary of Safety and Effectiveness

K202455

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

Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne - Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24

Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: +1(954) 660 3528

Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35

Date: 2020.12.22

2) 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: AIXPLORER® MACH 20, AIXPLORER® MACH 30, SUPERSONIC MACH40, SUPERSONIC MACH30 & SUPERSONIC MACH20 Ultrasound Diagnostic Systems

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

3) Substantially Equivalent/Predicate Devices

AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems (K191007), cleared on 10/25/2019

{14}------------------------------------------------

4) Description of Device

5) Indication for Use

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, 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.

The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.

{15}------------------------------------------------

	SuperSonic Imagine	SuperSonic Imagine
	Aixplorer MACH range sw V2(predicates)	AIXPLORER® MACH / SUPERONIC MACH range sw V2
510(k) Number	K191007	Unassigned
Classification Name	Ultrasonic Pulsed Doppler Imaging System(892.1550)Ultrasonic Pulsed Echo Imaging System(892.1560)Diagnostic Ultrasound Transducer(892.1570)	Identical
Class	Class II	Identical
Intended Use	Diagnostic ultrasound imaging, soft tissueelasticity imaging, fluid flow analysis of thehuman body	Identical
General Description	General purpose, mobile, softwarecontrolled diagnostic ultrasound system. Toacquire ultrasound data and to display thedata in various modes of operation.Consists of two parts: the system consoleand the transducer. The system consolecontains the user interface, a display,system electronics and optionalperipherals (printers, etc...).	Identical
Clinical Applications	Abdominal (liver, kidney, spleen)Small organs (*)MusculoskeletalFetalGYNCardiac (non invasive)Adult and neonatal cephalic	Identical
	SuperSonic Imagine	SuperSonic Imagine
	Pediatric	Identical
	Urology	Identical
	Vascular	Identical
	Peripheral vascular	Identical
	Trans-rectal	Identical
	Trans-vaginal	Identical
Imaging modes
Conventional	B-Mode (Harmonic, Fundamental)	Identical
	M-Mode	Identical
	PW	Identical
	CW	Identical
	Color Doppler	Identical
	Amplitude Doppler	Identical
	Microvascular (Angio PL.U.S)	Identical
Other	Spatial compounding, Panoramic	Identical
	Contrast	IdenticalAddition of Contrast availability on clinicalapplications.
	Combination of modes	Identical
	ShearWave Elastography	Identical
	Strain Elastography	Identical
Design
Cart	Mobile cart based product with controlpanel and monitor	Identical
Controls	Typical ultrasound imaging controls (gain,depth mode select...)	Identical
Biopsy guide	Available	Identical
	SuperSonic Imagine	SuperSonic Imagine
Track	Track 3 (Acoustic Output Display)	Identical
Patient ContactMaterials	Yes, per ISO 10993-1	Identical
Acoustic Outputwithin FDAguidelines	Yes, as per NEMA UD-3	Identical

Image Review	Yes	Identical
MeasurementPackage	Yes	Identical
CalculationPackage	Yes	Identical
Report	Yes	Identical
General Safety	Conforms to IEC60601-1, 60601-1-2,60601-2-37	Identical

Labeling	Conforms to 21 CFR Part 801	Identical

6) Summary of Technological Characterisitics – New Device compared to Predicates

{16}------------------------------------------------

{17}------------------------------------------------

Note:

Note:
*: Breast, Thyroid, Testicle, etc
**:--- means not applicable

:: --- means not applicable

{18}------------------------------------------------

7) A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

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 demonstratecompliance with the "Accoustic OutputMeasurement Standard for Diagnostic UltrasoundEquipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstratecompliance with the "Standard For Real TimeDisplay Of Thermal And Mechanical AcousticOutput Indices On Diagnostic UltrasoundEquipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriatedevice category.

Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.

The above testing confirmed that the Aixplorer® MACH / SUPERSONIC MACH Systems perform according to 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).

8) 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.

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 devices listed in item 3.

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.