The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).

Device Description

The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, 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 function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.

AI/ML Overview

This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® Ultrasound Diagnostic System, indicating that clinical data was not required for its clearance because it uses the same technology and principles as its predicate devices. Therefore, the document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria derived from a human-in-the-loop or standalone AI performance study.

Specifically, section 8 of the summary (page 24) explicitly states: "Clinical data is not required as the Aixplorer® System uses the same technology and principles as predicate devices."

As a result, I cannot provide the requested information, which would typically be found in a clinical study report for an AI/ML medical device. This 510(k) submission is for a conventional ultrasound system, not an AI-powered diagnostic device in the way a modern AI/ML submission would be.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like design representing the snakes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 16, 2016

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

Re: K161999

Trade/Device Name: AIXPLORER® Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 8, 2016 Received: November 9, 2016

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161999

Device Name

AIXPLORER® Ultrasound Diagnostic System

Indications for Use (Describe)

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.

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

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

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

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

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

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510(k) number (if known):

Device Name: AIXPLORÉR® Ultrasound System

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

Clinical Application		B	M	PWD	CWD	ColorDoppler	Combined (Specify)	Other* (Specify)
General(Track 1 Only)	Specific(Tracks 1 & 3)
Ophthalmic	Ophthalmic	P	P	P	P	P	P, 1, 3, 4, 11	P, 5, 6, 10
Fetal Imaging &Other	Fetal	P	N	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10, 11 - N13,14
	Intra-operative (Specify) vascular,abdominal, small organs	P		P		P	P, 1, 3, 4	P, 5, 6, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P	P	P	P, 1, 2, 3, 4 - N 12	P, 5, 6, 7, 8, 9, 10- N 14
	Neonatal Cephalic	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic	P	P	P	P	P	P, 1, 3, 4	P, 5, 6
	Trans-rectal	P	P	P	P	P	P, 1, 2, 3, 4	P, 5,6, 7, 8
	Trans-vaginal	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8 - N 10, 11
	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, 10 - N14
	Musculo-skeletal (Superficial)	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9, 10 - N14
	Intravascular
	GYN	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 11, 14
	Pelvic	P	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 11, 14
	Other (Specify)
Cardiac	Cardiac Adult	N	N	N	N	N	N 1, 3, 4, 5, 11
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9, 10
	Other (Specify)	P	P	P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Eastography

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™Eastography

8: Imaging Guidance for Biopsies

Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow +

Shearw ave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

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

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

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

AND/OR

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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: SL15-4 transducer (1D Linear Array Transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined (Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Fetal
Other	Abdominal	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9 - N14
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P 1, 2, 3, 4 - N12	P 5, 6, 7, 8, 9 - N14
	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 - N14
	Musculo-skeletal (Superficial)	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9 - N14
	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 1, 3, 4	P 5, 6, 8, 9
Vessel	Other (Specify)	N		N		N	N 1, 3, 4	N 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

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

Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging

3D Imaging
Combined modes include: B + M mode

11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Eastography

13: CEUS (Contrast Enhancement UltraSound)

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

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

510(k) Number (if known):

Device Name: SC6-1 transducer (curved array transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P, 1, 3, 4, 11	P, 5, 6
Other	Abdominal (including urology)	P	N	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9 - N11
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	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)	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	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Pelvic	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P			P	P 1, 3, 4	P 5, 6, 8, 9
	Other (Specify)	P	P			P	P 1, 3, 4	P 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding
™

6: Spatial Compounding
7: ShearWave"MElastography
8: Imaging Guidance for Biopsies

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

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

Prescription Use	X	AND/OR
(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)

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510(k) Number (if known):

Device Name: SE12-3 transducer (endocavitary transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P 1, 3, 4, 11	P 5, 6
	Abdominal
	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
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	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)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 11
	Pelvic	P	P	P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 11
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P 1, 3, 4	P 5, 6, 8
	Other (Specify)		P

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

6: Spatial Compounding
7: ShearWave™Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Eastography

13: CEUS (Contrast Enhancement UltraSound)

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

ShearWave
™
Elastography

8: Imaging Guidance for Biopsies

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

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

510(k) Number (if known):

Device Name: SLV16-5 transducer (motorized linear transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	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)
PeripheralVessel	Peripheral vessel	P	P	P		P	P 1, 3, 4	P 5, 6, 8, 9, 10
	Other (Specify)

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

6: Spatial Compounding
7: ShearWave™Elastography

8: Imaging Guidance for Biopsies

AND/OR

Prescription Use	X
(Part 21 CFR 801 Subpart D)

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

12: Combined modes include: Color flow +Shearw ave™ Eastography

11: Combined modes include: B+ M modes

13: CEUS (Contrast Enhancement UltraSound)

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

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

9: Panoramic Imaging

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

510(k) Number (if known):

Device Name: SL10-2 transducer (linear transducer)

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

Clinical Application		B	M	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
General(Track 1 Only)	Specific(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9 - N 13,14
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P	P	P, 1, 2, 3, 4N 12	P, 5, 6, 7, 8, 9 - N14
	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 - N14
	Musculo-skeletal (Superficial)	P	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9 - N14
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P, 1, 3, 4	P, 5, 6, 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 (K142100)

Additional Comments:

Additional Comments:
1: Combined modes include: B

1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

Combined modes include: B+ Shear wave Elastic
Combined modes include: B+ Pulse Wave

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

7: Shearwave Elastography
8: Imaging Guide for Biopsy

8: Imaging Guidance for Biopsies

12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)

9: Panoramic Imaging

: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

11: Combined modes include: B+ M modes

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

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

510(k) Number (if known):

Device Name: SMC12-3 transducer (micro-curved transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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 (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

6: Spatial Compounding
7: ShearWave™Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Eastography

13: CEUS (Contrast Enhancement UltraSound)

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

ShearWave™ Elastography

8: Imaging Guidance for Biopsies

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: XP5-1 transducer (Phased Array transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P		P	P	P	P 1, 3, 4	P 5, 6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P	P	P	P 1, 3, 4	P 5, 6
	Neonatal Cephalic
	Adult Cephalic	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	N	N	N	N	N	N 1, 3, 4, 5,11
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P	P	P	P 1, 3, 4	P 5, 6
	Other (Specify)	P		P	P	P	P 1, 3, 4	P 5, 6
Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal
	Intra-operative (Specify) Vascular,abdominal, small organs	P	P	P		P	P 1, 3, 4	P 5, 6, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P 1, 3, 4	P 5, 6, 9 - N 2, 7
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P		P	P 1, 3, 4	P 5, 6, 9 - N 2, 7
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P 1, 3, 4	P 5, 6, 9 - N 2, 7
	Musculo-skeletal (Superficial)	P	P	P		P	P 1, 3, 4	P 5, 6, 9 - N 2, 7
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P 1, 3, 4	P 5, 6, 9
	Other (Specify)	P	P	P		P	P 1, 3, 4	P 5, 6, 9
N = new indication; P = previously cleared by FDA (K142100)
Additional Comments:1: Combined modes include: B+ Color Flow2: Combined modes include: B+ ShearWave™ Elastography3: Combined modes include: B+ Pulsed Wave4: Combined modes include: B+ Pulsed Wave + Color Flow5: Harmonic Imaging6: Spatial Compounding7: ShearWave™ Elastography		9: Panoramic Imaging10: 3D Imaging11: Combined modes include: B+ M modes12: Combined modes include: Color flow + Shearwave™ Elastography13: CEUS (Contrast Enhancement UltraSound)14: Angio PL.U.S (Color Doppler improvement)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N, 1, 3, 4, 11	N, 5, 6
	Abdominal (including urolology)	N	N	N	N	N 1, 2, 3, 4,11	N 5, 6, 7, 8, 9, 13,14
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 13
	Small Organ (Breast, Thyroid, Testicle,Prostate, penis, etc...)	N	N	N	N	N 1, 2, 3, 4	N 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	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8,14
	Pelvic	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 14
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N 1, 3, 4	N 5, 6, 8
	Other (Specify)	N	N	N	N	N 1, 3, 4	N 5, 6, 8

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

6: Spatial Compounding
7: ShearWave™Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging
11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Eastography

13: CEUS (Contrast Enhancement UltraSound)

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

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

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

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

AND/OR

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

510(k) Number (if known):

Prescription Use X

(Part 21 CFR 801 Subpart D)

Device Name: SLH20-6 transducer (linear transducer)

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)

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

AND/OR

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

510(k) Number (if known):

Device Name: XC6-1 transducer (curved array transducer)

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 (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

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

7: Shearwave """ Elastograph

8: Imaging Guidance for Biopsies

11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Eastography

9: Panoramic Imaging

13: CEUS (Contrast Enhancement UltraSound)

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

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)

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

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

510(k) Number (if known):

Device Name: SEV12-3 transducer (endocavitary transducer)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N, 1, 3, 4, 11	N, 5, 6, 10
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid, Testicle,Prostate, penis, etc...)	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8,10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8,10
	Trans-vaginal	N	N	N	N	N 1, 2, 3, 4, 11	N 5, 6, 7, 8,10
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	N	N	N	N	N 1, 2, 3, 4, 11	N 5, 6, 7, 8,10
	Pelvic	N	N	N	N	N 1, 2, 3, 4, 11	N 5, 6, 7, 8,10
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Eastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding
™

6: Spatial Compounding
7: ShearWave™Elastography

8: Imaging Guidance for Biopsies

11: Combined modes include: B+ M modes

9: Panoramic Imaging

12: Combined modes include: Color flow +Shearw ave™ Eastography

13: CEUS (Contrast Enhancement UltraSound)

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

(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

510(k) Number (if known):

Device Name: SL18-5 transducer (1D Linear Array Transducer)

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Fetal
Other	Abdominal	N	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 9, 14
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	N	N	N	N	N	N 1, 2, 3, 4N 12	N 5, 6, 7, 8, 9, 14
	Neonatal Cephalic	N	N	N	N	N	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)	N	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 9,14
	Musculo-skeletal (Superficial)	N	N	N	N	N	N 1, 2, 3, 4	N 5, 6, 7, 8, 9,14
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N	N	N	N 1, 3, 4	N 5, 6, 8, 9
Vessel	Other (Specify)	N	N	N	N	N	N 1, 3, 4	N 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K142100)

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging

3: Combined modes include: B+ Pulsed Wave

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

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™Eastography

8: Imaging Guidance for Biopsies

Prescription Use X (Part 21 CFR 801 Subpart D)

y 10. 3D imaging
11. Combined mo

AND/OR

9: Panoramic Imaging 11: Combined modes include: B+ M modes

12: Combined modes include: Color flow +Shearw ave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

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

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

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

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510(k) Summary of Safety and Effectiveness

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

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: 2016/06/30

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, if known:
  Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: AIXPLORER® Ultrasound Diagnostic System

Classification:

Regulatory Class: II

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

Classification Name:	21 CFR Section	Product Code		Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN		ToshibaDevice(predicate)	EsaoteDevice(predicate)	SuperSonic ImagineAIXPLORER®(predicate)	SuperSonicImagineAIXPLORER®(predicate)	SuperSonicImagineAIXPLORER®(new device)
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO	510(k) Number	K133761	K133905	K142100	K132274	Unassigned
Diagnostic Ultrasound Transducer	892.1570	90-ITX	ClassificationName	Ultrasonic Pulsed Doppler ImagingSystem (892.1550)Ultrasonic Pulsed Echo ImagingSystem (892.1560)Diagnostic Ultrasound Transducer(892.1570)	Identical	Identical	Identical	Identical
Class	Class II	Identical	Identical	Identical	Identical
Intended Use	---	---	---	Diagnosticultrasoundimaging, softtissue elasticityimaging, fluidflow analysis ofthe humanbody.	Identical
GeneralDescription	General purpose, mobile, softwarecontrolled diagnostic ultrasoundsystem. To acquire ultrasounddata and to display the data invarious modes of operation.	Identical	Identical	Identical	Identical

3) Substantially Equivalent/Predicate Devices

AIXPLORER® Ultrasound Imaging System (K142100), cleared on 11/20/2014 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Esaote S.p.A Ultrasound Imaging System (K133905), cleared on 04/15/2014 Toshiba System, Diagnostic Ultrasound (K133761), cleared on 22/04/2014

4) Description of Device

5) Intended Use

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

The SuperSonic Imagine AXPLORER® utrasound diagnostic system is in the following applications: Abdominal, Small Urgans, Musculoskeletal, Superficial Musculosketal, Vascular, Intraperative, OB-GYN, Pelvic, Pediatic, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

The system also provides the ability to measure anatomical, Small Organs, Musculoskeletal, Superficial Musculoskeleta, Peripheral Vascular, Intraperative, GYN, Pediatic, Unlogy, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Feta/Obsterios, Cardiac).

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

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

{19}------------------------------------------------

Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
Consists of two parts: the systemconsole and the transducer. Thesystem console contains the userinterface, a display, systemelectronics and optionalperipherals (printers, etc...).Includes physical knobs andbuttons of the main control paneland the user interface whichconsists of a Touch Panel, toaccess additional less-frequently-used controls, and theAlphanumeric Keyboard to enterpatient data and other text.	Identical	Identical	Identical	Identical
SWE DynamicRange	---	Adjustable range capabilityand numeric display withscale	Adjustablerangecapability andnumericdisplay withscale	Identical toK132274 andK142100
ClinicalApplications	Abdominal,Small Organs*MusculoskeletalSuperficial MusculoskeletalFetalGYNCardiac	IdenticalIdenticalIdenticalIdenticalIdenticalIdentical---	IdenticalIdenticalIdenticalIdentical--Identical---	IdenticalIdenticalIdenticalIdenticalIdenticalIdenticalIdentical
	Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
	Adult and neonatal cephalic	Identical	Identical	Identical	Identical
	Pediatric	Identical	Identical	Identical	Identical
	Urology	Identical	Identical	Identical	Identical
	Vascular	Identical	Identical	Identical	Identical
	Peripheral Vascular	Identical	Identical	Identical	Identical
	Intra-operative	Identical	Identical	Identical	Identical
	---	Laparoscopic	---	---	---
	Trans-rectal	---	Identical	Identical	Identical
	Trans-vaginal	Identical	Identical	Identical	Identical
Imaging Modes
	B-mode (Harmonic/Fundamental)	Identical	Identical	Identical	Identical
	M-mode,	Identical	Identical	---	Identical
	PW,	Identical	Identical	Identical	Identical
Conventional	CW (continuous Wave),	Identical	---	---	---
	Color Doppler,	Identical	Identical	Identical	Identical
	Amplitude Doppler (CPI)	Identical	Identical	Identical	Identical
	Microvascular SMI	---	---	---	Identical (calledAngio PL.U.S)
Other
	Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
	Spatial Compounding, Panoramic,Contrast	Identical	Identical	Identical	Identical
		Identical	---	---	Identical
	---	Elastography	Identical	Identical	Identical
	B-mode+Color,	Identical,	Identical	Identical	Identical
	B-mode+Color+ PW	Identical	Identical	Identical	Identical
Combination	B-mode +PW	Identical	Identical	Identical	Identical
		Identical	---	---	Identical
	---	---	B-mode+Elastography	Identical	Identical
Design
Cart	Mobile cart-based product withcontrol panel and monitor	Identical	Identical	Identical	Identical
Controls	Typical ultrasound imagingcontrols including power output,gain, depth, focus, freeze, PRF,mode select	Identical	Identical	Identical	Identical

Transducers
	Linear Array	Identical	Identical	Identical	Identical
	Curved Array	Identical	Identical	Identical	Identical
	Phased Array	Identical	Identical	Identical	Identical
Transducertypes	---	Laparoscopic probe	---	---	---
	Motorized Linear Probe	Identical	Identical	Identical	Identical
	Microconvex probe	Identical	Identical	Identical	Identical

Biopsy guide	Yes	Yes	Yes	Yes	Yes
	Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
Track	Track 3 (Acoustic Output Display)	Identical	Identical	Identical	Identical
Patient ContactMaterials	Yes, per ISO-10993-1	Identical	Identical	Identical	Identical
Acoustic Outputwithin FDAguidelines	Yes, as per NEMA UD-3	Identical	Identical	Identical	Identical
Image Review	Yes	Identical	Identical	Identical	Identical
MeasurementPackage	Yes	Identical	Identical	Identical	Identical
CalculationPackage	Yes	Identical	Identical	Identical	Identical
Report	Yes	Identical	Identical	Identical	Identical
General Safety	Conforms to IEC 60601-1, IEC60601-1-2, IEC 60601-2-37	Identical	Identical	Identical	Identical
Labeling	Conforms to 21 CFR Part 801	Identical	Identical	Identical	Identical
GeneralDescription	Consists of two parts: the systemconsole and the transducer. Thesystem console contains the userinterface, a display, systemelectronics and optionalperipherals (printers, etc...).	Identical	Identical	Identical	Identical
GeneralDescriptionSWE DynamicRange	Includes physical knobs andbuttons of the main control paneland the user interface whichconsists of a Touch Panel, toaccess additional less-frequently-used controls, and theAlphanumeric Keyboard to enter	Identical	Identical	Identical	Identical toK142100 andK132274
Toshiba	Esaote	SuperSonic Imagine	SuperSonicImagine	New device
patient data and other text.
---	---	---	Adjustablerangecapability andnumericdisplay withscale	Identical toK132274

{20}------------------------------------------------

{21}------------------------------------------------

{22}------------------------------------------------

{23}------------------------------------------------

Note:

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

:. --- means not applicable

{24}------------------------------------------------

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 3.1 Edition	All applicable electrical, basic safety and essential performance tests.
IEC 60601-1-2 3rd Edition	All applicable testing pertaining to electromagnetic compatibility.
IEC 60601-2-37 2nd Edition	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.

In addition to the referenced standards testing, performance tests were conducted with respect to new transducers (XC6-1, SEV12-3 and SL18-5).

The above testing confirmed that the Aixplorer® System performs 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® System 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

Clinical data is not required as the Aixplorer® System uses the same technology and principles as predicate devices.

9) Conclusion

The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2003) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during manufacturing process to ensure compliance with these standards. Consequently, according tests performed, the opinion of SuperSonic Imagine is the submission device is as safe and effective as the predicate devices cited in item 3.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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