Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms in the device description or performance studies. The device functions are described as identical to predicate devices using standard ultrasound imaging modes.

Therapeutic

No
The device is described as an "ultrasound diagnostic system" intended for "imaging and measurement of anatomical structures" and aid in "clinical management," which are diagnostic rather than therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "ultrasound diagnostic systems." The "Device Description" also mentions it is used to "perform non-invasive diagnostic general purpose ultrasound imaging studies."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "cart-based ultrasound imaging system" and includes hardware components like transducers, a scan converter, a monitor, and a control panel.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are ultrasound diagnostic systems used for non-invasive diagnostic general purpose ultrasound imaging studies. This involves using sound waves to create images of internal structures of the body, not analyzing samples taken from the body.
Intended Use: The intended use describes imaging and measurement of anatomical structures and fluid flow within the human body. It does not mention any analysis of biological samples.

Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
Specific: Ophthalmic, Fetal, Liver, Kidney, Spleen, Breast, Thyroid, Testicle, Prostate, penis.

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

IEC 60601-1 Ed.3.1: All applicable electrical, basic safety and essential performance tests.
IEC 60601-1-2 Ed.4: All applicable testing pertaining to electromagnetic compatibility.
IEC 60601-2-37 Ed.2.1: All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3): All tests applicable in order to demonstrate compliance with the "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment".
NEMA UD 3 (Rev. 2): All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment".
ISO 10993-1: Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category.

Key results: 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).

Clinical tests: Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191007

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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.

1

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

2

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)

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.

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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3

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	Color
Doppler	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, 21
N : 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, 8
N : 13
	Trans-vaginal	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 11
N : 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,
20
N : 13
	Musculo-skeletal (Superficial)	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 14, 15,19,
20
N : 13
	Intravascular
	GYN	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8 11, 14
N : 13
	Pelvic	P	P	P		P	P : 1, 2, 3, 4	P: 5, 6, 7, 8,11, 14
N : 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, 15
N : 13
Vessel	Other (Specify)	P		P		P	P : 1, 3, 4	P : 5, 6, 8, 9, 10, 15
N : 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

4

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

5

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	Color
Doppler	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, 8
N: 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, 8,11,14
N: 13
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 11,14
N: 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, 8
N: 13
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8
N: 13
Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)		B	M	PWD	CWD	Color
Doppler	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, 8
N : 13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
N : 13
	Trans-vaginal		P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8
N : 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, 8
N : 13
	Pelvic		P	P	P	P	P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8
N : 13
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)		P		P		P	P: 1, 3, 4	P: 5, 6, 8
N : 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

6

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	Color
Doppler	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)
Peripheral
Vessel	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	Color
Doppler	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)
Peripheral
Vessel	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	Color
Doppler	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)
Peripheral
Vessel	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 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
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)
Peripheral
Vessel	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	Color
Doppler	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)
Peripheral
Vessel	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	Color
Doppler	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, 8
N : 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, 14
N : 13
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14
N : 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, 8
N : 13
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8
N : 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

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.

5) Indication for Use

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 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 tissue
elasticity imaging, fluid flow analysis of the
human body	Identical
General Description	General purpose, mobile, software
controlled diagnostic ultrasound system. To
acquire ultrasound data and to display the
data in various modes of operation.

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 essential
performance tests.
IEC 60601-1-2 Ed.4	All applicable testing pertaining to electromagnetic
compatibility.
IEC 60601-2-37 Ed.2.1	All applicable testing pertaining to the particular
requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstrate
compliance with the "Accoustic Output
Measurement Standard for Diagnostic Ultrasound
Equipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstrate
compliance with the "Standard For Real Time
Display Of Thermal And Mechanical Acoustic
Output Indices On Diagnostic Ultrasound
Equipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)
Memorandum - #G95-1 - per the appropriate
device 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.