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, 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).

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 adiustable 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 for the imaging modes: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.

AI/ML Overview

The provided 510(k) summary for the SuperSonic Imagine AIXPLORER® ultrasound system does not contain information about acceptance criteria or a specific study proving the device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy. This type of premarket notification primarily focuses on demonstrating substantial equivalence to predicate devices, and the submitted evidence is generally limited to non-clinical performance data and adherence to recognized standards.

Therefore, the requested information elements related to clinical study design, sample sizes for training/test sets, expert qualifications, and specific performance metrics cannot be extracted from this document, as they are not present.

The document emphasizes adherence to safety standards and comparison to predicate devices, rather than a clinical performance study with defined acceptance criteria and performance metrics.

Here's a breakdown of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to:

Safety: Compliance with IEC 60601-1, UL 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 regarding electrical, basic safety, essential performance, and electromagnetic compatibility.
Acoustic Output: Compliance with NEMA UD 2 and NEMA UD 3, and FDA guidance limits (September 9, 2008, 510(k) diagnostic ultrasound guidance) for Mechanical Index, TIS/TIB, ISPTA(d), and ISPPA(d).
Biocompatibility: Compliance with ISO 10993-1.
Functionality: Verification tests for "Panoramic" and "High PRF" features to ensure they "perform according to the stated intended use."

The document states: "All data fell within pre-determined product specifications and external standard requirements." However, it does not detail these "pre-determined product specifications" in a quantifiable manner for clinical performance.

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

Not applicable / Not provided. The document describes non-clinical performance testing against standards and feature verification, not a clinical study with a test set of patient data.

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

Not applicable. No clinical ground truth establishment or expert review for a test set is described.

4. Adjudication Method:

Not applicable. No clinical study or adjudication process is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe a MRMC study or any comparative effectiveness study with human readers. The regulatory submission path chosen (510(k)) relies on substantial equivalence to predicate devices rather than a direct demonstration of clinical superiority or improvement with AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, implicitly, for non-clinical aspects. The non-clinical performance data, particularly the "Panoramic Measurement Verification Tests" and "High PRF Measurement Verification Tests," represent testing of the device's algorithms/features in a standalone capacity (without human interaction) to ensure they function as intended per product specifications. However, this is not a clinical standalone performance evaluation for diagnostic accuracy.

7. Type of Ground Truth Used:

For the non-clinical tests (e.g., Panoramic, High PRF verification), the "ground truth" would be the expected output or measurement values based on the device's design specifications and engineering principles. For compliance with standards, the ground truth is adherence to the technical requirements and limits defined by those standards.

8. Sample Size for the Training Set:

Not applicable / Not provided. The device is a diagnostic ultrasound system, not an AI/ML device that typically involves a distinct "training set" in the context of learning algorithms for diagnostic tasks. Its functionality relies on established ultrasound physics and signal processing.

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

Not applicable. As above, a "training set" and associated ground truth for training are not relevant to the type of device and submission described here.

Summary

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K121329

AUG 2 4 2012 510(k) Summary of Safety and Effectiveness

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: 011 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

Corresponding Official:

Jacques Souquet Chief Executive Officer Telephone: 011 33 442 99 24 35

Date: 2012/08/21

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: 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 (K102041), cleared on 10/13/2010 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.

6) Indication for Use

7) Safety Considerations

As a Track 3 ultrasound device, the SuperSonic Imagine AIXPLORER® ultrasound system is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment" AIUM/NEMA 2004a published by the National Electrical Manufacturers Association as UD -3. With respect to limits on acoustic outputs. the SuperSonic Imagine AIXPLORER® ultrasound system complies with the FDA quideline limits set in the September 9, 2008, 510(k) diagnostic ultrasound guidance.

With regard to general safety, the SuperSonic Imagine AIXPLORER® ultrasound system scanner is designed to comply with IEC 60101 - 1 (2005) Medical Electrical Equipment. Part 1: General Requirements for Basic Safety and Essential Performance, and IEC 60601 - 2-37 (2007): Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

Mechanical Index	1.9 (Maximum)
TIS/TIB	0.1 - 4.0 (Range)
ISPTA (d)	720 mW/cm2
ISPPA (d)	0 - 700 W/cm2

The device's acoustic output limits are:

The limits are the same as predicate Track 3 devices. These considerations apply to all modes the system offers.

8) Comparison to Predicate Devices

The SuperSonic Imagine AIXPLORER® system and transducers are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness.

The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. .
The systems have the same clinical indications for use.

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. The systems have the same B-Mode (grayscale imaging) and Doppler capabilities.
. The systems have similar capability in terms of harmonic imaging, spatial compound imaging, elastography imaging and other image post-processing features to improve the image quality and aid in clinical evaluation and diagnosis.
. The transducers are similar in materials, manufacture and clinical capability.
. The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
. The systems have acoustic power levels which are below the applicable FDA limits.
. The systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
. The systems have been found to be manufactured in compliance with approved electrical and physical safety standards.

Nonclinical Performance Data 9)

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 appropriatedevice category.

In addition to the referenced standards testing, SuperSonic Imagine conducted the following performance tests with respect to the Panoramic and High PRF features:

Panoramic Measurement Verification Tests
High PRF Measurement Verification Tests

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).

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10) Conclusion

The documentation provided demonstrates that:

1. The system and transducers are substantially equivalent to the predicate devices.
1. There are no new questions of safety and effectiveness concerning the SuperSonic Imagine AIXPLORER® ultrasound system and transducers.
1. The ultrasound device has been scientifically evaluated and has been demonstrated to be at least as safe and effective as the predicate devices cited in item 3. The system's acoustic power levels are below the applicable FDA limits.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 2 4 2012

Jacques Souquet, Ph.D. Chief Executive Officer SUPERSONIC imagine Les Jardins de la Duranne 510, rue Rene Descartes - Bat. E et F 13 857 AIX-EN-PROVENCE CEDEX FRANCE

Re: K121329

Trade/Device Name: AIXPLORER® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 2, 2012 Received: July 2, 2012

Dear Dr. Souquet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

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

Transducer Model Number

SL15-4 (1D Linear Array) SC6-1 (Curved Array) SE12-3 (Endocavitary)

SLV 16-5 (Motorized Linear) SL10-2 (Linear) SMC12-3 (Micro-Curved)

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 vour 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely Yours

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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510(k) number (if known):

Device Name: AIXPLORER® Ultrasound System

Device Name: Alixi EURER® Online of the malysis of the human body as follows:

Indications for Use:

Indications for Use.
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following The SuperSonic Tinagile Anxi CONEN® Citaceae Chical Musculoskeletal, Vasculoskeleta, Vascular, Peripheral
applications: Abdominal, Small Organs, Musculoskeletal, Superficial applications: Abdominal, Omail Organo) metal, Trans-vaginal and Neonatal Cephalic.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, The System also "provides" the "admy" to "htoudro" anatomical CSYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal Cephalic).

Prescription Use XX_____ OR Over-The-Counter Use _

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 11

(Division Sign-Off)
Division of Radiological Devices
DIVD

Stok 8/2/3/29

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510(k) number (if known):

Device Name: AIXPLORER® Ultrasound System

Device Name: AIXPLORER® Olirasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as files

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
Other	Abdominal (including urolology)	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Neonatal Cephalic	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 9
	Adult Cephalic
	Trans-rectal	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8
	Trans-vaginal	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Musculo-skeletal (Superficial)	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Intravascular,
	GYN	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, 10
	Pelvic	P	P			P	P, 1, 2, 3, N, 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, N, 4	P, 5, 6, 7, 8, 10, N, 9
	Other (Specify)	P	P			P	P, 1, 2, 3, N, 4	P, 5, 6, 7, 8, N, 9

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

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

o: Hannomo millionio
6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

(Division Sign-Off)

Division of Radiological Devices

10: 3D Imaging

111

510k

OR Over-The-Counter Use Prescription Use _XX (Part 21 CFR 801 Subpart D) (21 CFR 801 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: SL15-4 transducer (1D Linear Array Transducer)

Device Name: SE 15-4 transdaoor (1D Einear Ana) 1 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, N, 4	P 5, 6, 7, 8, N, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, N, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, N, 9
	Neonatal Cephalic	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)	P		P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, N, 9
	Musculo-skeletal (Superficial)	P		P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, N, 9
	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, 2, 3, N, 4	P 5, 6, 7, 8, N, 9
Vessel	Other (Specify)

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

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

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

sion Sian-Off

Division of Radiological Devices

10: 3D Imaging

(D)v

510

OR Over-The-Counter Use Prescription Use XX (Part 21 CFR 801 Subpart D) (21 CFR 801 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: SC6-1 transducer (curved array transducer)

Device Name: SOO- Fitansador (our rou and) « and flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

/ Idaltonal Sommons:
1: Combined modes include: B+ ShearWave™ Elastography
2: Combined modes include: B+ ShearWave™ Elastography
11: Combined modes include: B+ ShearWave™

3: Combined modes include: B+ Pulsed Wave

5: 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

dioiogical Devices

9: Panoramic Imaging

10: 3D Imaging

510k

OR Over-The-Counter Use Prescription Use _XX

(Part 21 CFR 801 Subpart D) (21 CFR 801 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)

Device Name: OE IL o transcover (maging 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	W	D	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P		W	D	P	P 1, 2, 3, N, 4	P 5, 6, 7, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P			W	D	P	P 1, 2, 3, N, 4	P 5, 6, 7, 8
	Trans-vaginal	P	P			W	D	P	P 1, 2, 3, N, 4	P 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Muscuio-skeletal (Superficial)
	Intravascular
	GYN		P			W	D	P	P 1, 2, 3, N, 4	P 5, 6, 7, 8
	Pelvic	P	P			W	D	P	P 1, 2, 3, N, 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			W	D	P	P 1, 2, 3, N, 4	P 5, 6, 7, 8
	Other (Specify)

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

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

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

(Division Sign-Off)

vision of Radiblogical Devices 0

10: 3D Imaging

the

210k

Prescription Use XX_______ OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 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: SLV16-5 transducer (motorized linear transducer)

Device Name: OLV ro-o tranddaoor (motorial a filter 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
Fetal Imaging &Other	Fetal
	Abdominal	P	P	P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, 10, N, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, 10, N, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	P	P	P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, 10, N, 9
	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, N, 4	P 5, 6, 7, 8, 10, N, 9
	Musculo-skeletal (Superficial)	P	P	P		P	P 1, 2, 3, N, 4	P 5, 6, 7, 8, 10, N, 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, 2, 3, N, 4	P 5, 6, 7, 8, 10, N, 9
	Other (Specify)

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

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

3: Combined modes include: B+ Pulsed Wave

Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging

Spatial Compounding

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

iplogical Devices

Imaging Guidance for
Panoramic Imaging

9: Panoramic Imaging

10: 3D Imaging

510k

OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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

510(k) Number (if known):

Device Name: SL10-2 transducer (linear transducer)

Device Name: SE 10-2 Iranoducer (mour itanodios)
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
Fetal Imaging& Other	Fetal
	Abdominal	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	Neonatal Cephalic	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, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	N	N			N	N, 1, 2, 3, 4	N, 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	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	Other (Specify)	N	N			N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

/ Latitional Somments
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
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

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

an Sign-Off ision of Radiological Devices

10: 3D Imaging

ામ Divisi

510k

__ OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Please do not write below this line-continue on another Page if needed)

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

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	FetalAbdominal	N	N	N	N	N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	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, etc...)	N	N	N	N	N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	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
	Musculo-skeletal (Superficial)	N	N	N	N	N	N, 1, 2, 3, 4	N, 5, 6, 7, 8, 9
	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, 2, 3, 4	N, 5, 6, 7, 8, 9

N = new indication; P = previously cleared by FDA (K102041)

Additional Comments:

1: Combined modes include: B+ Color Flow

Additional Commont:
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

6: Spatial Compounding
7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

18 M

(Division Sign-Off) of Radiological Devices

9: Panoramic Imaging

10: 3D Imaging

ﻟﻠ

510

OR Over-The-Counter Use Prescription Use __XX

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

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.