SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM

K081676 · Medison Co., Ltd. · IYN · Jul 2, 2008 · Radiology

Device Facts

• Record ID: K081676
• Device Name: SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The SONOACE X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.

Device Story

SONOACE X6 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays images in B-mode, M-mode, color/power Doppler, PW/CW spectral Doppler, harmonic imaging, and freehand 3D. Operated by healthcare professionals in clinical settings. The system provides real-time acoustic output display (mechanical and thermal indices) and includes analysis packages for anatomical measurements. Output is viewed on an LCD display to assist clinicians in diagnostic decision-making and patient management.

Clinical Evidence

Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157, and ISO 10993 for biocompatibility.

Technological Characteristics

Mobile diagnostic ultrasound system. Employs ultrasonic pulsed Doppler and pulsed echo imaging. Connectivity includes LCD display. Safety/performance standards: UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157, ISO 10993. Software-controlled with real-time acoustic output display (mechanical/thermal indices).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients across clinical applications including general, gynecology, abdominal, OB, renal, urology, vascular, small parts, fetal heart, breast, musculoskeletal, cardiac, TCD, and neonatal. Includes guidance for biopsy and infertility monitoring.

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

• SA8000 SE Diagnostic Ultrasound System (K043455)
• SONOACE X8 Diagnostic Ultrasound System (K063580)

Submission Summary (Full Text)

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1681676
SONOACE X6 Diagnostic Ultrasound System

### JUL - 2 2008 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

### 1. Submitter's Information: 21 CFR 807.92(a)(1)

MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

### Contact Person:

Mr. Kyung-Am, Shim Regulatory Affairs Manager

| Telephone: | 82.2.2194.1381 |
|------------|--------------------|
| Facsimile: | 82.2.2194.1399 |
| Email: | [e-mail] |

### Data Prepared: May 15, 2008

### 2. Name of the device:

### Common/Usual Name:

Diagnostic Ultrasound System and Accessories

### Proprietary Name:

SONOACE X6 Diagnostic Ultrasound System

| Classification Names: | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

### 3. Identification of the predicate or legally marketed device:

K043455, 12/21/2004, SA8000 SE Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System

### 4. Device Description:

The SONOACE X6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes on the LCD display.

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The SONOACE X6 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The SONOACE X6 has been designed to meet the following product safety standards:

- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2. EMC requirements for Medical Equipment
- NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157. Declaration of the acoustic output
- ISO10993, Biocompatibility

### 5. Intended Uses:

The SONOACE X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:

General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.

### 6. Technological Characteristics:

The SONOACE X6 is substantially equivalent to the SA8000 SE Diagnostic Ultrasound System, cleared via K043455, and the SONOACE X8 Diagnostic Ultrasound System, cleared via K063580. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

END of 510(K) Summary

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of three abstract shapes resembling birds in flight, arranged in a diagonal line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081676

Trade/Device Name: SONOACE X6 Diagnostic 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: June 16, 2008 Received: June 17, 2008

Dear Mr. Job:

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.

JUL - 2 2008

This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE X6 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

| C3-7EP |
|------------|
| C4-9ED |
| NER4-9ES |
| NEV4-9ES |
| HL5-12ED |
| L5-12/50EP |

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
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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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Marvland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Arqui M. Whang

S Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

:

. Enclosure(s)

: 上一篇:

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### Section 4.3 INDICATIONS FOR USE

## DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No .: Device Name:

SONOACE X6 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|--------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Note 2,4,5,6,7,8 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6,8 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 3, 7, 8 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2,5,6,8 |
| | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2,5,6,8 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5 6 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological De 510(k) Number

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510(k) No .:

Device Name: C3-7EP for use with SONOACE X6

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| Fetal Imaging<br>& Other | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color, B/PD, B/Color/Color M, B/Color/Color M, B/Color/Steered CW, B/Steered CW Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Homi Ta Wiz

(Division Sian-C ductive. Abdominal and Division of Re Radiological De 510(k) Number

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510(k) No .:

| Device Name:<br>C4-9ED for use with SONOACE X6 | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------|------------------------------|---|---------------------------------------------------|-----|-----|----------|-----------|-----------|--|--|--|
| Intended Use:<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
| | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | | | |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | | |
| & Other | Pediatric | P | P | P | | P | Note 1 | Note 2, 8 | | | |
| | Small Organ (See Note 5) | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 2, 8 | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | | |
| | Intra-luminal | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | Note 1 | Note 2 8 | | | |
| Vessel | Other (spec.) | | | | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color/PW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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ian-Off (Division Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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510(k) No .:

| Device Name:<br>NER4-9ES for use with SONOACE X6 | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|--|
| Intended Use:<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| (Track I only) | (Tracks I & III) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8 | | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8 | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/ColorPW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

how to write

Division 510/k) N

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510(k) No .:

| NEV4-9ES for use with SONOACE X6 | | | | | | | | |
|------------------------------------------------------------------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | |
| | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Lorry M. Witz

(DivisionSign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081626

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510(k) No.:

Device Name: HL5-12ED for use with SONOACE X6

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Clinical Application Mode of Operation (*includes simultaneous B-mode) General Specific B M PWD CWD Color Combined* Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric P P Note 2, 5, 6 P P Note l Small Organ (See Note 5) P P P P Note 1 Note 2, 5, 6 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) P P P Note 2, 5, 6 P Note 1 Musculo-skel. (Superfic.) P P P Note 2, 5, 6 P Note l Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel P P p P Note 1 Note 5, 6 Vessel Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Aornai In Wty

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510(k) No.:

Device Name: L5-12/50EP for use with SONOACE X6 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|--------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| (Track I only) | (Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6 | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 5, 6 | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Signature

Division o Radiologi 510/k) N

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510(k) No .:

#### Device Name: P2-4AH for use with SONOACE X6

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation (* includes simultaneous B-mode) General Specific B M PWD CWD Color Combined* Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal P P P P P Note l Note 4, 7 Intra-operative (See Note 6) Intra-operative (Neuro.) Laparoscopic Fetal Imaging & Other Pediatric Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic P P p P P Note 1 Note 4, 7 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult p P P p Note I P Note 4 7 Cardiac Cardiac Pediatric p P P P P Note 1 Note 4, 7 Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Dorge In Wly
Division Sign-Off

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510(k) No .:

| CW 2.0 for use with SONOACE X6<br>Device Name: | | | | | | | | |
|------------------------------------------------|------------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | P | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW, B/Color/PW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

Vorquita White

(Division S! ប្រទេទ្រ

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510(k) No .:

Device Name: CW 4.0 for use with SONOACE X6

| Device Name: | CV-4.0 for use with SONOACE X6 | |
|---------------|-----------------------------------------------------------------------------------|---------------------------------------------------|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |
| | Clinical Application | Mode of Operation (*includes simultaneous B mode) |

| Clinical Application | | Mode of Operation (* includes simultaneous B-mode) | | | | | | |
|----------------------|------------------------------|----------------------------------------------------|---|-----|-----|----------|-----------|---------|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| & Other | Pediatric | | | | P | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | P | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | P | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K063580; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BM, B/PW, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Harmonic Imaging

Note 8: 3D imaging

_
(Division Sign-Off)

Divisio Radio 510/k