Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

• K Number: K191007
• Device Name: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
• Manufacturer: Supersonic Imagine
• Date Cleared: 2019-10-25 ( 192 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The SuperSonic Imagine AIXPLORER® 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 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, Intraoperative, OB-CYN, Pelvic, Pediatric, Urology, Transrectal, 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 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.

Device Description

The SuperSonic Imagine AIXPLORER® 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, micro-convex, 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), M-mode, Color Flow (and sub-modes as CFI-Color Flow Imaging, CPI-Color Power 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 ShearWaye™ elastography and Strain Elastography.

Predicate Devices

K180572, K173090, K171233

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional ultrasound imaging modes and measurements.

Therapeutic

No
The device is described as an "ultrasound diagnostic system" intended for imaging and measurement, indicating its use in diagnosis rather than direct therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "ultrasound diagnostic systems and transducers." It also lists various applications for "imaging and measurement of anatomical structures," and describes the use of viscoelasticity and stiffness measurements as an "aid to clinical management."

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, LCD monitor, and control panel.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the device is for "general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body." It is used for "imaging and measurement of anatomical structures." While it aids in clinical management, it does so through imaging and measurement within the body, not by examining specimens outside the body.
• Device Description: The description details a cart-based ultrasound imaging system that produces images and performs measurements. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
• Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) or performing tests on samples outside the body, which are hallmarks of IVD devices.

Therefore, the SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic system is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SuperSonic Imagine AIXPLORER® 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 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, 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 with liver disease.

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

IYN, IYO, ITX

Device Description

The SuperSonic Imagine AIXPLORER® 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, micro-convex, 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), M-mode, Color Flow (and sub-modes as CFI-Color Flow Imaging, CPI-Color Power 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 Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic

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.
Reference Standard: IEC 60601-1 Ed.3.1
Tests Performed: All applicable electrical, basic safety and essential performance tests.

Reference Standard: IEC 60601-1-2 Ed.4
Tests Performed: All applicable testing pertaining to electromagnetic compatibility.

Reference Standard: IEC 60601-2-37 Ed.2.1
Tests Performed: All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

Reference Standard: NEMA UD 2 (Rev. 3)
Tests Performed: All tests applicable in order to demonstrate compliance with the "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment".

Reference Standard: NEMA UD 3 (Rev. 2)
Tests Performed: 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".

Reference Standard: ISO 10993-1
Tests Performed: Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category.

The above testing confirmed that the Aixplorer® 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).

Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side.

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.

K180572, K173090, K171233

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2019

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

Re: K191007

Trade/Device Name: AIXPLORER® MACH 30, AIXPLORER® MACH 20, Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 7, 2019 Received: October 10, 2019

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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K191007

Device Name

AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems

Indications for Use (Describe)

The SuperSonic Imagine AIXPLORER® 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 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, Intraoperative, OB-CYN, Pelvic, Pediatric, Urology, Transrectal, 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 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) number (if known):

Device Name: AIXPLORER® MACH 30 (SSIP95030) and AIXPLORER® MACH 20 (SSIP95020) 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	P	P			P	P : 1, 3, 4, 11	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, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 11, 13,
14, 15, 16 - N: 21, 22
	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 -
N : 18, 19, 20, 21
	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
	Trans-vaginal	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 11
	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 -
N : 19, 20
	Musculo-skeletal (Superficial)	P	P			P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 14, 15 -
N : 19, 20
	Intravascular
	GYN	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 11, 14
	Pelvic	P	P	P		P	P : 1, 2, 3, 4	P: 5, 6, 7, 8, 11, 14
	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
Vessel	Peripheral vessel	P		P		P	P : 1, 3, 4	P : 5, 6, 8, 9, 10, 15
	Other (Specify)	P		P		P	P : 1, 3, 4	P : 5, 6, 8, 9, 10, 15
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, 2, 3, 4	P: 5, 6, 7, 8, 9, 13,14, 15,
16 – N: 21,22
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 15, 16 –
N: 14, 21, 22
	Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)	P	P	P	P	P	P: 1, 2, 3, 4,
12	P: 5, 6, 7, 8, 9, 14, 15 – N:
20, 21, 22
	Neonatal Cephalic	P	P	P	P	P	N, 1, 2, 3, 4	N, 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14,15 – N:
20
	Musculo-skeletal (Superficial)	P	P	P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15 - N:
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	P	P: 1, 3, 4	P: 5, 6, 8, 9, 15
	Other (Specify)	P	P	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		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
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	P: 1, 3, 4, 11	P: 5, 6
Other	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 -
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: 9, 14, 21, 22
	Small Organ (Breast, Thyroid, Testicle,
Prostate, penis, etc...)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	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: 11
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14 - N: 11
	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
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

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

Prescription Use _ X

(Part 21 CFR 801 Subpart D)

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

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Diagnostic Ultrasound Indications for Use

510(k) Number (if known):

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:

9: Panoramic Imaging

9. Panoramic Image
10. 3D Image

10: 3D Imaging

11: Combined modes include: B+ M mode

Prescription Use _ X (Part 21 CFR 801 Subpart D) 20: Combined mode: B Mode + Strain + SWE

• 21: Vi PLUS
  22: Att PLUS & SSp PLUS AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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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:

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

2: Combined modes include: B+ ShearWave™ Elastography

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

Additional Comments:

5: Harmonic Imaging

9: Panoramic Imaging

10: 3D Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

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
  Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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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:

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...
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	Trans-vaginal	P	P	P		P	P: 1, 2, 3, 4,
11	P: 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P: 1, 2, 3, 4,
11	P: 5, 6, 7, 8
	Pelvic	P	P	P		P	P: 1, 2, 3, 4,
11	P: 5, 6, 7, 8
	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
	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, 10
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	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		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		P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Musculo-skeletal (Superficial)	P	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	Peripheral vessel	P	P	P	P		P: 1, 3, 4	P: 5, 6, 8, 9, 10
Vessel	Other (Specify)
	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		12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography		13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
	5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies		15: Needle PL.U.S
16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow
	9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode		19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS
Prescription Use	X						AND/OR
Over-The-Counter Use
	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	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	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	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		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	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	P: 1, 3, 4	P: 5, 6, 8, 9
	Other (Specify)	P		P	P	P	P: 1, 3, 4	P: 5, 6, 8, 9

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

Prescription Use

X

(Part 21 CFR 801 Subpart D)

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

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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:

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

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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	P	P: 1, 3, 4	P: 5, 6
	Neonatal Cephalic
	Adult Cephalic	P	P	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 (K180572)
	1: Combined modes include: B+ Color Flow

1. Combined modes include: D+ Color Flow
2. Combined modes include: B+ ShearWave™ Elastography

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 Imaqinq

11: Combined modes include: B+ M mode

Use X
(801 Subpart D)

graphy

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

Prescription Use	X
------------------	---

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

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

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)

3: Combined modes include: B+ Pulsed Wave

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

2: Combined modes include: B+ ShearWave™ Elastography

• 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

Prescription Use (Part 21 CFR 801 Subpart D) 17: Combined mode include: B+ Continuous Wave

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

19: Strain Elastography

15: Needle PL.U.S

16: Brightness ratio

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use

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			P
	Abdominal (including urolology):
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

Prescription Use _ X (Part 21 CFR 801 Subpart D) 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

AND/OR

Over-The-Counter Use

1 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use

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 urolology):
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
	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
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14
	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
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

13: CEUS (Contrast Enhancement UltraSound)

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

20: Combined mode: B Mode + Strain + SWE

17: Combined mode include: B+ Continuous Wave

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

15: Needle PL.U.S

16: Brightness ratio

21: Vi PLUS

19: Strain Elastography

22: Att PLUS & SSp PLUS

13

510(k) Summary of Safety and Effectiveness K191007

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: [phone]

Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: [phone]

Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: [phone]

Date: 2019.10.24

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 Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20

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 range Ultrasound Imaging System (K180572), cleared on 05/29/2018 Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 Resona 7 (K171233) cleared on 09/12/2017

14

4) Description of Device

The SuperSonic Imagine AIXPLORER® 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, micro-convex, 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), M-mode, Color Flow (and sub-modes as CFI-Color Flow Imaging, CPI-Color Power 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 ShearWaye™ elastography and Strain Elastography.

5) Indication for Use

The SuperSonic Imagine AIXPLORER® 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 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. 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 with liver disease.

15

| | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------|
| | Aixplorer MACH
range sw V1 | Aplio i900, i800 and
i700 V2.0 | Resona 7 | AIXPLORER® MACH
range sw V2 |
| | (predicates) | (predicate) | | |
| 510(k) Number | K180572 | K173090 | K171233 | K191007 |
| Classification
Name | Ultrasonic Pulsed
Doppler Imaging
System (892.1550)
Ultrasonic Pulsed Echo
Imaging System
(892.1560)
Diagnostic Ultrasound
Transducer (892.1570) | Identical to K180572 | Identical to K180572 | Identical to K180572 |
| Class | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasound
imaging, soft tissue
elasticity imaging, fluid
flow analysis of the
human body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body | Diagnostic Ultrasound
imaging or fluid flow
analysis of the human
body | Identical to K180572 |
| | General purpose,
mobile, software
controlled diagnostic
ultrasound system. To
acquire ultrasound data
and to display the data
in various modes of
operation. | Identical | Identical | Identical |
| General
Description | Consists of two parts:
the system console
and the transducer.
The system console
contains the user
interface, a display,
system electronics
and optional
peripherals (printers,
etc...). | Identical | Identical | Identical |
| Clinical
Applications | Abdominal (liver,
kidney, spleen) | Identical | Identical | Identical |
| | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| | Small organs (*) | Identical | Identical | Identical |
| | Musculoskeletal | Identical | Identical | Identical |
| | Fetal | Identical | Identical | Identical |
| | GYN | Identical | Identical | Identical |
| | Cardiac (non invasive) | Cardiac | Identical | Identical |
| | Adult and neonatal
cephalic | Identical | Identical | Identical |
| | Pediatric | Identical | Identical | Identical |
| | Urology | Identical | Identical | Identical |
| | Vascular | Identical | Identical | Identical |
| | Peripheral vascular | Identical | Identical | Identical |
| | Trans-rectal | Identical | Identical | Identical |
| | Trans-vaginal | Identical | Identical | Identical |
| Imaging modes | | | | |
| | B-Mode (Harmonic,
Fundamental) | Identical | Identical | Identical |
| | M-Mode | Identical | Identical | Identical |
| | PW | Identical | Identical | Identical |
| Conventional | CW | Identical | Identical | Identical |
| | Color Doppler | Identical | Identical | Identical |
| | Amplitude Doppler | Identical | Identical | Identical |
| | Microvascular (Angio
PL.U.S) | ---(**) | -- | Identical |
| Other | Spatial compounding,
Panoramic | Identical | Identical | Identical |
| | Contrast | Identical | Identical | Identical |
| | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| Combination of modes | Identical | Identical | Identical | |
| ShearWave
Elastography | Identical | Identical | Identical | |
| Strain Elastography | -- | Identical to K191007 | Identical to K191007 | |
| Design | | | | |
| Cart | Mobile cart based
product with control
panel and monitor | Identical | Identical | Identical |
| Controls | Typical ultrasound
imaging controls (gain,
depth mode select...) | Identical | Identical | Identical |
| Biopsy guide | Available | Identical | Identical | Identical |
| Track | Track 3 (Acoustic
Output Display) | Identical | Identical | Identical |
| Patient Contact
Materials | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic Output
within FDA
guidelines | Yes, as per NEMA
UD-3 | Identical | Identical | Identical |
| Image Review | Yes | Identical | Identical | Identical |
| Measurement
Package | Yes | Identical | Identical | Identical |
| Calculation
Package | Yes | Identical | Identical | Identical |
| Report | Yes | Identical | Identical | Identical |
| General Safety | Conforms to
IEC60601-1, 60601-1-
2, 60601-2-37 | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR
Part 801 | Identical | Identical | Identical |

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

16

17

Note:

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

:: --- means not applicable

18

| | SuperSonic
Imagine | Canon
Medical
System | Mindray Medical
International | Supersonic
Imagine |
|------------------|------------------------------------|------------------------------------|-------------------------------------------------|------------------------------------|
| | Aixplorer
MACH range
(sw v1) | Aplio i900;
i800 & i700
v2.0 | Resona 7 | Aixplorer
MACH range
(sw v2) |
| 510(k)
number | K180572 | K173090 | K171233 | K191007 |
| Vi PLUS | No | Yes, SWD | No | New |
| Att PLUS | No | Yes, ATI | No | New |
| SSp PLUS | No | No | Yes, SSC Sound speed
correction/Compensation | New |

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

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.

The above testing confirmed that the Aixplorer® 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).

Engineering test of Strain Elastography between Aixplorer® MACH and Mindray Resona 7 confirms the equivalence between Aixplorer® MACH and its predicate Mindray Resona 7 on a quantitative and qualitative side.

8) 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.