AIXPLORER

K121329 · Supersonic Imagine · IYN · Aug 24, 2012 · Radiology

Device Facts

• Record ID: K121329
• Device Name: AIXPLORER
• Applicant: Supersonic Imagine
• Product Code: IYN · Radiology
• Decision Date: Aug 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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.

Device Story

Cart-based ultrasound system for non-invasive diagnostic imaging; utilizes linear, curved, micro-convex, and motorized linear array transducers. Inputs: acoustic signals processed via scan converter; outputs: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, and ShearWave™ elastography displayed on LCD monitor. Operated by clinicians in clinical settings. System allows image capture, measurement, and report generation. Facilitates clinical evaluation and diagnosis through enhanced image quality and elastography; supports biopsy guidance. Benefits include non-invasive diagnostic assessment of tissue and fluid flow.

Clinical Evidence

Bench testing only. Performance verified through compliance with electrical safety (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-37), acoustic output standards (NEMA UD-2, UD-3), and biocompatibility (ISO 10993-1). Additional verification testing performed for Panoramic and High PRF measurement features. All results met pre-determined specifications.

Technological Characteristics

Cart-based ultrasound system; LCD monitor; scan converter; linear, curved, micro-convex, and motorized linear array transducers. Complies with IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound safety), and NEMA UD-3 (acoustic output). Biocompatible materials per ISO 10993-1. Modes: B-Mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D, and ShearWave™ elastography.

Indications for Use

Indicated for use in Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, and Neonatal Cephalic applications. Provides anatomical structure measurements for these same applications.

Regulatory Classification

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.

Predicate Devices

• AIXPLORER® Ultrasound Imaging System (K102041)
• Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786)
• Philips iU22 Ultrasound System (K093563)

Submission Summary (Full Text)

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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: [phone]

Distributed by: SuperSonic Imagine, Inc. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: [phone]

Corresponding Official:

Jacques Souquet Chief Executive Officer Telephone: [phone]

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

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.

## 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

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).

## 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 essential<br>performance tests. |
| UL 60601-1 1st Edition | All applicable electrical, basic safety and essential<br>performance tests specific to the U.S.A. |
| IEC 60601-1-1 2nd Edition | All applicable tests pertaining to Medical Electrical<br>Systems. |
| IEC 60601-1-2 3rd Edition | All applicable testing pertaining to electromagnetic<br>compatibility. |
| IEC 60601-2-37 2nd Edition | All applicable testing pertaining to the particular<br>requirements for the safety of ultrasonic medical<br>diagnostic and monitoring equipment. |
| NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstrate<br>compliance with the "Accoustic Output<br>Measurement Standard for Diagnostic Ultrasound<br>Equipment". |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate<br>compliance with the "Standard For Real Time<br>Display Of Thermal And Mechanical Acoustic<br>Output Indices On Diagnostic Ultrasound<br>Equipment". |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k)<br>Memorandum - #G95-1 - per the appropriate<br>device 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.
- 2) There are no new questions of safety and effectiveness concerning the SuperSonic Imagine AIXPLORER® ultrasound system and transducers.
- 3) 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 [phone].

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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>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,<br>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) | | | | | | | | |
| Peripheral<br>Vessel | 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(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,<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>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,<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | B | M | P | W | D | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| | Ophthalmic | | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| | Small Organ (for example Breast, Thyroid,<br>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) | | | | | | | | | | |
| Peripheral<br>Vessel | 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)

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

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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | |
| | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>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,<br>Thyroid, Testicle, Prostate, penis,<br>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) | | | | | | | | |
| Peripheral<br>Vessel | 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

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

iplogical Devices

8. Imaging Guidance for
9. 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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,<br>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) | | | | | | | |
| Peripheral<br>Vessel | 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

C

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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal<br>Abdominal | 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,<br>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)