The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

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

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

Device Description

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system 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 array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with inteorated 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, caplure 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 for the imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.

AI/ML Overview

The provided 510(k) submission (K132171) for the SuperSonic Imagine AIXPLORER® ultrasound system does not include a clinical study with acceptance criteria for device performance in the sense of an AI/human reader comparative effectiveness study, or standalone algorithm performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to performance standards for a general-purpose ultrasound system. The device itself is an ultrasound imaging system, not an AI-powered diagnostic tool with specific performance metrics like sensitivity or specificity for disease detection.

Here's an breakdown of the information provided based on your request, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance Study for SuperSonic Imagine AIXPLORER® Ultrasound System (K132171)

1. A table of acceptance criteria and the reported device performance

There are no specific quantitative acceptance criteria or reported device performance metrics in the provided document that would typically be found for an AI-enabled diagnostic device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various industry standards and showing the device performs similarly to predicate devices across various imaging modes and applications.

The document states: "All data fell within pre-determined product specifications and external standard requirements." The study thus demonstrates that the new device's performance aligns with these established standards and its predicate's characteristics.

Implicit Acceptance Criteria and Reported Device Performance (Compliance with Standards):

Acceptance Criteria (Implied)	Reported Device Performance (Compliance Status)
Compliance with IEC 60601-1 3rd Edition (Electrical safety)	All applicable tests passed.
Compliance with UL 60601-1 1st Edition (Electrical safety, USA)	All applicable tests passed.
Compliance with IEC 60601-1-1 2nd Edition (Medical systems)	All applicable tests passed.
Compliance with IEC 60601-1-2 3rd Edition (EMC)	All applicable tests passed.
Compliance with IEC 60601-2-37 2nd Edition (Safety of ultrasonic diagnostic equipment)	All applicable tests passed.
Compliance with NEMA UD 2 (Rev. 3) (Acoustic Output Measurement)	All applicable tests passed.
Compliance with NEMA UD 3 (Rev. 2) (Real Time Display of Acoustic Output Indices)	All applicable tests passed.
Compliance with ISO 10993-1 (Biocompatibility)	Applicable tests passed.
Performance of Fetal/Obstetrics features	Confirmed by performance tests.
Equivalence in Intended Use and Imaging Modes to Predicate Devices (K121329, K112255, K072786, K093563)	Demonstrated through comparative tables and functional descriptions.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical data is not required as the Aixplorer System uses the same technology and principles as predicate devices." Therefore, there is no test set of clinical data from patients and no information on data provenance. The testing conducted was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical test set was used, there were no experts involved in establishing ground truth for a test set. The validation relies on technical compliance with standards and comparison to predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

As there was no clinical test set and no ground truth established by experts, no adjudication method was employed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or is mentioned. The device is a general-purpose ultrasound system, and the submission does not describe any AI-assisted features that would necessitate such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. The submission solely focuses on the performance of the ultrasound system itself in terms of technical specifications and safety standards, as it is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" was defined by established technical standards and specifications (e.g., acoustic output limits, electrical safety parameters, biocompatibility requirements) and the characteristics of the predicate devices. There was no clinical ground truth established from patient data.

8. The sample size for the training set

Not applicable. This device is an ultrasound imaging system, not an AI/machine learning algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. As above, there was no training set.

Summary

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K132171
Page 1 of 5

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. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: +1(425) 686 6380

SEP 24 2013

Corresponding Official:

Jacques Souquet Chief Executive Officer Telephone: +33 442 99 24 35

Date: 2013/07/12

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

Classification:

Regulatory 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® Ultrasound Imaging System (K121329), cleared on 08/24/2012 AIXPLORER® Ultrasound Imaging System (K112255), cleared on 08/28/2012 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010

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4) Description of Device

5) Intended Use

The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

	Philips iu22(predicateK093563):	Siemens AcusonS2000 ™(predicateK072786)	SuperSonicImagineAIXPLORER®(predicateK121329)	SuperSonicImagineAIXPLORER®(predicateK112255)	SuperSonicImagineAIXPLORER®(submission-device)
	--**	General Radiology	--**	--**	--**
	Abdominal,Small Organs*	Identical	Identical	Identical	Identical
	Musculoskeletal	Identical	Identical	Identical	Identical
	--	SuperficialMusculoskeletal	Identical	Identical	Identical
	Fetal	Identical	--	--	Identical
ClinicalApplications	--	Transcranial	--	--	--
	--	OB	--	--	Identical
	--	GYN	Identical	Identical	Identical
	Cardiac	Identical	--	--	--
	--	Pelvic	Identical	Identical	Identical
	Adult andneonatalcephalic	Identical	Identical (forneonatal cephalic)	--	Identical (forneonatal cephalic)
	Pediatric	Identical	Identical	Identical	Identical
	Urology	Identical	Identical	ldentical	Identical
		Vascular	ldentical	Identical	Identical
	PeripheralVascular	Identical	Identical	Identical	Identical
	Ophthalmic	t ---		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----
	Intra-operative	---	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---
	Laparoscopic	---	---	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---
	Trans-rectal	----	Identical	Identical	ldentical
	Trans-vaginal	ﺴﻌ	ldentical	Identical	ldentical
	Fetal echo	ーーー		----	Identical

lmagingModes
	B-mode,	Identical	Identical	Identical	Identical
	M-mode,	Identical		---	Identical
	PW.	Identical	Identical	Identical	ldentical
Conventional	CW (continuousWave),	Identical	---	---	----
	Color Doppler,	ldentical	Identical	Identical	Identical
	AmplitudeDoppler	ldentical	ldentical	Identical	Identical
	Harmonicimaging,Spatial	Identical	Identical	Identical	Identical
Other	Compounding,Panoramic,	Identical	ldentical	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Identical
	Contrast	Identical		----	---
	---	Identical	Identical	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	---	Elastography	ldentical	ldentical	Identical
	B-mode+Color,	Identical,	Identical	ldentical	ldentical
	B-mode+Color+PW	Identical	Identical	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Identical
Combination	B-mode +PW	Identical	Identical	ldentical	İdentical
	B-mode+M-mode	Identical	---	ーーー	Identical
		B-mode+Elastography	Identical	Identical	Identical

Transducers
	Linear Array	Identical	ldentical	Identical	Identical
Transducer	Curved Array	Identical	Identical	ldentical	Identical
types	Phased Array	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-	-	-
	Laparoscopicprobe			---	---
	MotorizedLinear ProbeMicroconvexprobe	Identical	Identical	Identical	Identical

Track	Track 3(AcousticOutput Display)	Identical	Identical	Identical	Identical
PatientContactMaterials	Yes, per ISO-10993- 1	Identical	Identical	Identical	Identical
AcousticOutputwithin FDAguidelines	Yes, as perNEMA UD-3	Identical	Identical	Identical	Identical
GeneralSafety	Conforms toIEC 60601-1,IEC 60601-2	Identical	Identical	Identical	Identical

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

SUPERSONIC IMAGINE

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SUPERSONIC IMAGINE

page 3 of 5

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Note:

*: Breast, Thyroid, Testicle, etc

**: ---- means not applicable

7) A brief discussion of the 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 3rd Edition	All applicable electrical, basic safety and essentialperformance tests.
UL 60601-1 1st Edition	All applicable electrical, basic safety and essentialperformance tests specific to the U.S.A.
IEC 60601-1-1 2nd Edition	All applicable tests pertaining to Medical ElectricalSystems.
IEC 60601-1-2 3rd Edition	All applicable testing pertaining to electromagneticcompatibility.
IEC 60601-2-37 2nd Edition	All applicable testing pertaining to the particularrequirements for the safety of ultrasonic medicaldiagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstratecompliance with the "Accoustic OutputMeasurement Standard for Diagnostic UltrasoundEquipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstratecompliance with the "Standard For Real TimeDisplay Of Thermal And Mechanical AcousticOutput Indices On Diagnostic UltrasoundEquipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 – per the appropriate

SUPERSONIC IMAGINE

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K132171
Page 5 of 5

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In addition to the referenced standards testing, performance tests were conducted with respect to Fetal/Obstetrics features.

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 nonclinical 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.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the body of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Dicument Control Center - WOBB-GOOD Silver Spring. MID 209-13-0002

September 24, 2013

Supersonic Imagine, S.A. % Mr. Aurelie Gruener Les Jardins de la Duranne 510 Rue René Descartes - Bât. E et F Aix -en-Provence Cedex 13 857 FRANCE

Re: K132171

Trade/Device Name: Aixplorer® Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX Dated: September 3, 2013 Received: September 3, 2013

Dear Mr. Gruener:

We have reviewed your Section 510(k) premarket notification of intent 10 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: CDRII does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Aixplorer®, as described in your premarket notification:

Transducer Model Number

SL15-4SC6-1	SE12-3SLV16-5	SL10-2SMC12-3
-----------------	-------------------	-------------------

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

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Page 2-Mr. Gruener

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) number (if known): 1388 1132171

Device Name: AIXPLORER® Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for Use:

Prescription Use (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)

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

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________

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510(k) number (if known):

Device Name: AIXPLORER® Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other (Specify)
General(Track 1 Only)	Specific(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N, 1, 3, 4, 11	N, 5, 6
Other	Abdominal (including urology)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Small Organ (Breast, Thyrold,Testicle, Prostate, penis, etc...)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Neonatal Cephalic	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8
	Trans-vaginal	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Musculo-skeletal (Superficial)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Intravascular
	GYN	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10
	Pelvic	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Other (Specify)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9

N = new indication: P = previously cleared by FDA (K121329)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Combined modes include: B+ Color Mow
2: Combined modes include: B+ ShearWave™
Ei

Elastography

3: Combined modes Include: B+ Pulsed Wave

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

Flow

5: Harmonic Imaging

(Parl 21 CFR 801 Subpart D)

Prescription Use

AND/OR

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

11: Combined modes include: B+ M modes

6: Spatial Compounding
7: ShearWave™ Elestography

9: Panoramic Imaging

10: 3D Imaging

r. Shearthove Guldance for Biopstes

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

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510(k) Number (if known):

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

Intended Use: Diagnostic ultrasound imaging or 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 1, 2, 3, 4	P 5, 6, 7, 8, 9
	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	P 5, 6, 7, 8, 9
	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
	Musculo-skeletal (Superficial)	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Other (Specify)
	N = new indication; P = previously cleared by FDA (K121329)

Additional Comments:

1: Combined modes include: B+ Color Flow

Gombined modes include: B+ ShearWave"™

Elastography

3: Combined modes include: 8+ Pulsed Wave

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

Flow

5: Hamonic Imaging

(Part 21 CFR 801 Subpart D)

Prescription Use

AND/OR

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

6: Spatial Compounding
7: ShearWave™ Elastography

9: Panoramic Imaging

8: Imaging Guidance for Biopsies

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)

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510(k) Number (if known):

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	P	CWD	ColorDoppler	Combined(Specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N, 1, 3, 4, 11	N, 5, 6
	Abdominal (including urology)	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 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, 2, 3, 4	P 5, 6, 7, 8, 9
	Other (Specify)	P		P		P	P 1, 2, 3, 4	P 5, 8, 7, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

Additional Comments:

1; Combined modes include: B+ Color Flow

1: Combined modes include: B+ Color Plow

ਮ

Elastography

3: Combined modes include: B+ Pulsed Wave

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

Flow 5: Harnonic Imaging

Prescription Use

(Part 21 CFR 80) Subpart D)

· 11: Combined modes include: B+ M modes

AND/OR

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

6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Blopsies

9: Panoramic Imaging

10: 3D Imaging

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510(k) Number (if known):

Device Name: SE12-3 transducer (endocavitary transducer)

Intended Use: Diagnostic ultrasound imaging or 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	N	N	N	N	N, 1, 3, 4, 11	N, 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 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 1, 2, 3, 4	P 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	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
	Other (Specify)	P	P		P		P 1, 2, 3, 4	P 5, 6, 7, 8

N = new indication; P = previously cleared by FDA (K121329)

Additional Comments:

Combined modes include: B+ Color Flow

1: Combined modes include: B+ Combined modes in
2: Combined modes include: B+ ShearWave™
Electoranhy Elastography

Bibliography

2: Combined mod

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

Flow

5: Harmonic Imaging

Prescription Use

6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsles 9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

5: Harnonic Imaging

(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)

Concurrence of CDRH: Office of in Vitro Diagnostics and Radiological Health (OIR)

Page 5 of 8

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

510(k) Number (if known):

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Canical Application	Mode of Operation
General(Track 1 Only)	Spocific(Tracks 1 & 3)	3	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, 10, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc }	p		2	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethrai
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventions!)	b		P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Musculo-skeletal (Superficial)	P		P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardlac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P		P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
Vessel	Other (Specify)
	N = new indication, P = previously cleared by FDA (K121320)

Additional Comments:

1: Combined modes Include: B+ Color Flow

Combined modes include: B+ ShearWave™

Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: 8+ Pulsed Wave + Color

Flow

5: Harmonic Imaging

Color 10: 30

ic Imaging

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

5: Harmonic Imaging

× Prescription Use (Part 21 CFR 801 Subpan 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)

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

Page 6 of B

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

510(k) Number (if known):

Device Name: SL10-2 transducer (linear transducer)

Intended Use: Diagnostic ultrasound imaging or 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, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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, etc...)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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
	Musculo-skeletal (Superficial)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
Vessel	Other (Specify)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

Additional Comments:

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

2: Combined modes include: B+ ShearWave'

Elastography

Prescription Use

3: Combined modes include: B+ Pulsed Wave

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

Flow

5: Hamonic Imaging

(Part 2) CFR 801 Subpart D)

11: Combined modes include: B+ M modes

AND/OR

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

6: Spatial Compounding
7: ShearWave™ Elastography

9: Panoramic Imaging

10: 3D Imaging

8: Imaging Guidance for Biopsies

(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)

Page 7 of 8

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

510(k) Number (if known):

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

Intended Use: Diagnostic ultrasound imaging or 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
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P, 1, 2, 3, 4
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)		P	P	P		P	P, 1, 2, 3, 4
	Neonatal Cephalic		P	P	P		P	P, 1, 2, 3, 4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)		P	P	P		P	P, 1, 2, 3, 4
	Musculo-skeletal (Superficial)		P	P	P		P	P, 1, 2, 3, 4
	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, 2, 3, 4	P, 5, 6, 7, 8, 9
Vessel	Other (Specify)	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

Additional Comments:

1: Combined modes include: B+ Color Flow

1: Combined modes include: B+ Color Plow
2: Combined modes include: B+ ShearWave™

ਮ

Elastography

3: Combined modes include: B+ Pulsed Wave

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

Flow

5: Harnonic Imaging

(Part 21 CFR 801 Subpart D)

Prescription Use

AND/OR

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

11: Combined modes include: B+ M modes

6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

(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)

Page 8 of 8

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.