ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM

K070813 · Medison Co., Ltd. · IYN · Apr 10, 2007 · Radiology

Device Facts

• Record ID: K070813
• Device Name: ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.

Device Story

ACCUVIX V10 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, Harmonic imaging, and PW Spectral Doppler modes. It also supports 3D imaging using mechanical scan probes. Operated by healthcare professionals in clinical settings, the system provides real-time acoustic output (mechanical and thermal indices) and measurement/analysis packages for anatomical structures and fluid flow. Output is viewed on an LCD display to assist in clinical diagnosis and decision-making, potentially benefiting patients through non-invasive diagnostic imaging and biopsy guidance.

Clinical Evidence

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

Technological Characteristics

Mobile diagnostic ultrasound system; LCD display; supports 2D, M-mode, Color/Power Doppler, PW/CW Doppler, Harmonic imaging, and 3D imaging. Biocompatible materials per ISO 10993-1. Complies with NEMA UD-2/UD-3 for acoustic output. Software-controlled. Transducers include various phased, convex, and linear arrays.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients across clinical applications including abdomen, obstetrics, gynecology, small parts (thyroid, parathyroid, breast, scrotum, penis), vascular, musculoskeletal, urology, and cardiac. 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

• ACCUVIX XQ Diagnostic Ultrasound System (K052911)
• SONOACE X8 Diagnostic Ultrasound System (K063580)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K070813". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The contrast between the characters and the background is high, making them easily readable.

#### 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: March 15, 2007

#### 2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

ACCUVIX V10 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:

K052911, 10/31/2005, ACCUVIX XQ Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System

#### 4. Device Description:

The ACCUVIX V10 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 imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the LCD display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode.

The ACCUVIX V10 has real time acoustic output display with two basic indices, a

510(k) Summary of Safety and Effectiveness

#### ATTACHMENT 1(b)

APR 1 0 2007

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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 V10 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 y
- 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 V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:

Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.

#### 6. Technological Characteristics:

The ACCUVIX V10 is substantially equivalent to the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911, 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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 1 0 2007

Re: K070813

Trade Name: ACCUVIX V10 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO and ITX Dated: March 23, 2007 Received: March 26, 2007

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 ACCUVIX V10 Diagnostic Ultrasound System, as described in your premarket use with the notification:

#### Transducer Model Number

| 3D2-5EH | 3D2-5EL | 3D2-6ET | 3D4-8ET | 3D4-9ES | C1-4EC |
|----------|---------|------------|-----------|---------|----------|
| C2-5EL | C2-6IC | C3-7IM | C4-9/10ED | EC4-9IS | NER4-9ES |
| NEV4-9ES | L4-7EH | L5-12/50EP | L5-12ID | L6-12IS | L8-15IS |
| P2-4AC | P3-5AC | P3-7AC | CW 2.0 | CW 4.0 | |

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Page 2 - Mr. Mark Job

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 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

If you have any questions regarding the content of this letter, please contact John Chen, Ph.D., at [phone].

Sincerely yours,

David R. Ingram

for

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

Enclosures

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### Section 4.3 INDICATIONS FOR USE

## DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT

510(k) No .: Device Name:

#### ACCUVIX V10 Diagnostic Ultrasound System 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) | 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 2,4,5,6,7,8,9 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 |
| | 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 2,5,6,8,9 |
| | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 |
| | 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, 9 |
| | 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 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

Note 9: Panoramic imaging

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

David h. Gyson

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

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

# 510(k) No .:

Device Name: 3D2-5EH for use with ACCUVIX V10

| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>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 | 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 | 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 | 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/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

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

Note 9: Panoramic imaging

David A. Ingram

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

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

510(k) No .:

| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow | | | | | | | | | | | |
|---------------------------|----------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|--|--|--|
| 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 | 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.) | | | | | | | | | | | |

580; E= added under Appendix E new indication: P= previously cleared

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

Note 9: Panoramic imaging

Daniel R. Szymon

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

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

| 510(k) No.: | | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D2-6ET for use with ACCUVIX V10 | | | | | | | |
| 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 | | | | | | | |
| | 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 vessel | | | | | | | |
| Peripheral<br>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/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

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

David A. Hyman

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

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

510(k) No.:

Device Name: 3D4-8ET for use with ACCUVIX V10

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 (Tracks I & III) (Track I only) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) P p P P Note 1 Notes 2, 7, 8 Abdominal Note 1 Notes 2, 7, 8 P P P P Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic Pediatric & Other Notes 2, 7, 8 P P P P Note l 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 K063580; 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/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

Note 9: Panoramic imaging

David A. Sayre

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

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

| 510(k) No.: | | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D4-9ES for use with ACCUVIX V10 | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | | | | | | | |
| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
| | | 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 | Notes 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | 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 | 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/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

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

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** (Per 21 CFR 801.109)

David A. Ingram

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

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

| 510(k) No.: | | | | | | | | |
|--------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | C1-4EC for use with ACCUVIX V10 | | | | | | | |
| 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<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 | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K060087; 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

Note 9: Panoramic imaging

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

Daniel A. Rogers

(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number

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

| 510(k) No.:<br>Device Name: | C2-5EL for use with ACCUVIX V10 | | | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| 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 | | | | | | | |
| | 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 | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K032329 and K052911; 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

Note 9: Panoramic imaging

Daniel A. Hagerman

(Division Sign-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number

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

| 510(k) No.: | | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|---------------------|----------------------|------------------|
| Device Name: | C2-6IC for use with ACCUVIX V10 | | | | | | | |
| 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 | | | | | | | |
| | 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 | | | | | | | |
| | Other (spec.) | | | | | | | |

K052911; E= added under Appendix E pi

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

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) Prescription Use (Per 21 CFR 801.109)

David A. Symon

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

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

510(k) No .:

| Device Name: | C3-7IM for use with ACCUVIX V10 |
|---------------|------------------------------------------------------------------------------------|
| 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 | 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 | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/…