ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM

K092159 · Medison Co., Ltd. · IYN · Jul 28, 2009 · Radiology

Device Facts

• Record ID: K092159
• Device Name: ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACCUVIX V20 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

Device Story

ACCUVIX V20 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in 2D, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, and Tissue Doppler modes. 3D/4D imaging is supported via mechanical scan probes. Operated by healthcare professionals in clinical settings. The system automatically displays mechanical and thermal indices for real-time acoustic output monitoring. It provides measurement and analysis packages for anatomical structures and fluid flow to assist clinical diagnosis. Output is viewed on an integrated LCD display, supporting clinical decision-making through visualization and quantitative analysis of patient anatomy and hemodynamics.

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, NEMA UD-3, IEC 61157, and ISO 10993-1 for biocompatibility.

Technological Characteristics

Mobile diagnostic ultrasound system. Materials comply with ISO 10993-1. Sensing via ultrasonic transducers (pulsed echo/Doppler). Energy source: electrical. Connectivity: standard ultrasound system interfaces. Software: system-controlled. Sterilization: applicable to transducers per manufacturer instructions. Safety standards: UL 60601-1, IEC 60601-2-37, NEMA UD-2/UD-3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in general, abdominal, obstetric, gynecologic, vascular, extremity, pediatric, cardiac, breast, urologic, neonatal cephalic, and trans-esophageal applications. Includes guidance for biopsy and infertility monitoring. Contraindications not specified.

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

• ACCUVIX V20 Diagnostic Ultrasound System (K080800)
• ACCUVIX XQ Diagnostic Ultrasound System (K052911)

Submission Summary (Full Text)

{0}------------------------------------------------

KC092159

510(k) Premarket Notification

### ACCUVIX V20 Diagnostic Ultrasound System

# 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

JUL 2 8 2009

Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager

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

Data Prepared: February 29, 2008

### 2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

ACCUVIX V20 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: K080800. ACCUVIX V20 Diagnostic Ultrasound System

K052911, ACCUVIX XQ Diagnostic Ultrasound System

### 4. Device Description:

The ACCUVIX V20 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode.

The ACCUVIX V20 has real time acoustic output display with two basic indices, a

ATTACHMENT 1(b)

{1}------------------------------------------------

510(k) Premarket Notification

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 ACCUVIX V20 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. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility

### 5. Intended Uses:

The ACCUVIX V20 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:

General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

### 6. Technological Characteristics:

The ACCUVIX V20 is substantially equivalent to the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K080800, and the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911. 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

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle symbol, with three stripes forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.

### Public Health Service

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

JUL 2 8 2009

Re: K092159

Trade/Device Name: ACCUVIX V20 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: July 15, 2009 Received: July 16, 2009

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.

This determination of substantial equivalence applies to the following transducers intended for use with the ACCUVIX V20 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3D2-6ET 3D4-8ET 3D4-9ES 3D5-9EK V2-6 V4-8 VS-9 V6-12 C2-5EL C2-6IC

C3-7IM C4-9/10ED EC4-91S ER4-9/10ED EV4-9/10ED L4-7EL L5-12/50EP L5-13IS L7-16IS LF5-12

{3}------------------------------------------------

| MPT4-7 | P3-8CA |
|--------|--------|
| P2-4AC | CW 2.0 |
| P2-4BA | CW 4.0 |
| P3-5AC | |

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

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 vou 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

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

Sincerely yours,
Helent leemer

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

510(k) Premarket Notification

### Section 4.3 INDICATIONS FOR USE

# DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No .:

Device Name: ACCUVIX V20 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<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 | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Note 2,4,5,6,7,8,9 |
| | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2,5,6,8,9 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 3, 7, 8 |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 3, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | N | N | N | N | N | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2,5,6,8,9 |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2,5,6,8,9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | N | N | N | N | N | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 5, 6, 9 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K080800; E= added under Appendix E

### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

510(k) Number

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | K092159 |

{5}------------------------------------------------

510(k) No .:

Device Name:

### 3D2-6ET for use with ACCUVIX V20 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| 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<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 | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | 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 K080800; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

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

510(k) Numbr

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off) |
|-----------------------------------------|
| Division of Reproductive, Abdominal and |
| Radiological Devices |

{6}------------------------------------------------

510(k) No .:

#### Device Name: 3D4-8ET for use with ACCUVIX V20 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) | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| & Other | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K080800; E= added under Appendix E

Additional Comments: .

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD 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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K092159 |

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

510(k) No.:

Device Name: 3D4-9ES for use with ACCUVIX V20
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 (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Other | Fetal ( <i>See Note 3</i> ) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | Note I | Notes 2, 7. 8 |
| | 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 Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K080800; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K092159 |

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

510(k) No .:

Device Name:

### 3D5-9EK for use with ACCUVIX V20

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

N= new indication; P= previously cleared under K080800; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

-
(Division Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K092159

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

510(k) No.:

#### Device Name: V2-6 for use with ACCUVIX V20 ﮧ ﺍ ITT

| 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 | Note 1 | Notes 2, 7, 8 |
| | Abdominal | 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 | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

510(k)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/CWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| Prescription Use (Per 21 CFR 801.109) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |

{10}------------------------------------------------

510(k) No.:

| Device Name: | V4-8 for use with ACCUVIX V20 | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 Imaging<br>& Other | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | 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 by FDA; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppier/CWD 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, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K092159 |

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

510(k) No.:

V5-9 for use with ACCUVIX V20 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 | | | | | | | |
| | Trans-rectal | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 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 by FDA; E= added under Appendix E

Additional Comments:

Color Doppier includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD 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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K092159 |

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

510(k) No .:

| V6-12 for use with ACCUVIX V20<br>Device Name: | | | | | | | | |
|-----------------------------------------------------------------------------------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>Intended Use: | | | | | | | | |
| 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 | N | N | N | | N | Note 1 | Note 2, 5, 6, 9 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 2, 5, 6, 9 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 9 |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note 1 | Note 5, 6, 9 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppier includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD

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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices. | |
| 510(k) Number | K092159 |

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

510(k) No.:

Device Name:

C2-5EL for use with ACCUVIX V20 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 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | 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 K080800; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: BM, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

510(k) Number

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: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

| Concurrence of CDRH, Office of Device Evaluation (ODE<br>Prescription Use (Per 21 CFR 801.109) | |
|------------------------------------------------------------------------------------------------|--|
| | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices 1 20 Q / L | |

O

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

510(k) No .:

#### C2-6IC for use with ACCUVIX V20 Device Name: 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 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | |…