DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

K091680 · Edan Instruments, Inc. · ITX · Jun 19, 2009 · Radiology

Device Facts

• Record ID: K091680
• Device Name: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
• Applicant: Edan Instruments, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jun 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DUS 6/DUS 3 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 6/DUS 3 is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Device Story

Portable digital B/W ultrasound system; utilizes array of probes (linear, convex, microconvex, transrectal, transvaginal) with 2.5MHz-10.0MHz frequency range. Emits ultrasound waves into body tissue; captures returned echoes; processes signals to generate images. Displays in B-Mode, 2B-Mode, 4B-Mode, M-Mode, or B/M-Mode. Operated by physicians or qualified healthcare professionals in clinics, ICUs, and emergency rooms. Provides real-time diagnostic imaging for clinical evaluation of various anatomical structures; aids in diagnostic decision-making; supports patient assessment through non-invasive visualization.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing per FDA guidelines, and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Portable digital B/W ultrasound system; pulsed echo imaging. Probes: linear, convex, microconvex, transrectal, transvaginal. Frequency: 2.5-10.0 MHz. Modes: B, 2B, 4B, M, B/M. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993. Software-controlled.

Indications for Use

Indicated for diagnostic ultrasound imaging/fluid flow analysis of fetus, abdomen, pediatrics, small organs, neonatal cephalic, cardiology, peripheral vessels, musculoskeletal (conventional/superficial), and urology (including prostate, transrectal, transvaginal) in clinical settings.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• DP-6600 Digital Ultrasonic Diagnostic Imaging System (K052113)
• DP-6600 Digital Ultrasonic Diagnostic Imaging System (K060949)

Submission Summary (Full Text)

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K091680

JUN 19 2009

# 510(k) Summary of Safety and Effectiveness

## Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:

ﺰ ﺍﻟﻤﺘﺤﺪﺓ

ﻟﻠﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Edan Instruments, Inc.

3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China

Tel .: [phone]

Fax: [phone]

Contact Person: Jiang yucai Prepare date: April 2, 2009

2. Device name and classification:

Device name: DUS 3/DUS 6 Digital Ultrasonic Diagnostic Imaging System

Classification Name: 892.1560 System, Imaging, Pulsed echo, Ultrasonic Product code: IYO

> 892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITX

Regulatory Class: II

3. Predicate Device: DP-6600 Digital Ultrasonic Diagnostic Imaging System. K052113 Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD DP-6600 Digital Ultrasonic Diagnostic Imaging System. K060949 Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

4. Device DUS 3/DUS 6 Digital Ultrasound Diagnostic Imaging System is a portable Description: digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

> It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10.0MHz.

The system consists of a main unit, a display and transducers.

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### 5. Intended Use:

The DUS 6/DUS 3 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 6/DUS 3 is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

## 6. Effectiveness and Safety Considerations:

### Clinical test:

Clinical testing is not required.

### Non-clinical test:

The following safety standards are conducted on the subject device:

- 1. IEC 60601-1 Electrical Safety
- 2. IEC 60601-1-2 Electromagnetic Compatibility
- 3. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9. 2008.
- 4. ISO 10993-1, ISO 10993-5 and ISO 10993-10

## 7.Comparison to the predicate device

Comparison to the predicate device, the subject device has the similar technology characteristics and has the same intended use, same design principle, same electrical classification, same measurement mode and same accuracy. The different between the subject device and predicate device primarily includes physical specifications, environment specifications, scanning angle, printer, display frame rate, Image depth range, all the above differences do not affect the usage, safety and effectiveness, and no new question is raised regarding the safety and effectiveness.

## 8. Substantially Equivalent Determination

Verification and validation testing was done on the DUS 3/DUS 6 Digital Ultrasonic Diagnostic Imaging System. This premarket notification demonstrates that DUS 3/DUS 6 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings spread and feathers represented by thick, curved lines.

Public Health Service

JUN 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edan Instruments, Inc. % Mr. Marc M. Mouser Manager & FDA Office Coordinator, Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K091680

Trade/Device Name: Digital Ultrasonic Diagnostic Imaging Systems (Models DUS3 and DUS6)

Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: May 27, 2009 Received: June 10, 2009

Dear Mr. Mouser:

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 Digital Ultrasonic Diagnostic Imaging Systems (Models DUS3 and DUS6), as described in your premarket notification:

### Transducer Model Number

## DUS 3 Digital Ultrasonic Diagnostic Imaging System

| C361-1 / C34 |
|--------------|
| C321-1 |
| L741 |
| E741 |
| F611-1 |

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### DUS 6 Digital Ultrasonic Diagnostic Imaging System

| C363-1 / C343-1 |
|-----------------|
| C321 |
| L743 |
| E743 |
| E613 |

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 Paul Hardy at [phone].

Sincerely yours,

Vorger M. Whay

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

### Enclosure(s)

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### Indication for Use

# 510(k) Number (if known): Kog 1680

Device Name: Digital Ultrasonic Diagnostic Imaging System (Models DUSS and DUS6)

The DUS 3 & DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynceology rooms, cxamination rooms, intensive care units, and emergency rooms.

Ihe DUS 3/ DUS 6 Digital Ultrasonic Diagnostic Imaging System is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound cvaluation of Fetus, Abdoment Pediatries; Small Organ; Neonaual Cephalic; Cardiology; Peripheral Vessel: Musculo-skeleton (both Conventional and Superlicial); Urology (including prostate); Transrecta and Transvagina.

× Prescription Use (2) CI'R Part 801 Subpart D) Or Over the Counter Use (21 CFR Part 801 Subpart C')

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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Hoa th Nha

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

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## Diagnostic Ultrasound Indications for Use Form .

#### DUS 3 Digital Ultrasonic Diagnostic Imaging System

Intended Use: Diagnostic ultrasound imaging or tluid that analysis of the human hody as follows:

| Clinical Application | Mode of Operation | | | | | | |
|------------------------------------|-------------------|---|-----|-----|---------------|-----------------------|---------------------|
| | B | M | PWD | CWD | Color Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | |
| Small Organ (Specify) | N | N | | | | N | |
| Neonatal Cephalic | N | N | | | | N | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | | | | N | |
| Musculo-skeletal (Superficial) | N | N | | | | N | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | N | N | | | | N | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | |
| Other (Specify) | | | | | | | |

N = new indication: P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: 13 t M

(IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHIFR PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription 1.ise (Per 2 l Clik 801.109)

-2 Page 2 of 13

Arni M. Khan

Olvision Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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### Diagnostic Ultrasound Indications for Use Form

### DUS 3 with C361-1 / C341 Transducer

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

| Clinical Application | Mode of Operation | | | | | | Other*<br>(Specify) |
|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appendix Additional comments: Combined mode: 13 M

(PLLASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER PAGE IF MELDED) Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

.

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Page 3 of 13

_
(Division Sign Off)

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

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## Diagnostic Ultrasound Indications for Use Form

### DUS 3 with C321-1 Transducer

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|--|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | |
| Abdominal | N | N | | | | N | | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | N | | |
| Small Organ (Specify) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | |
| Intravascular | | | | | | | | |
| Other (Specify) | | | | | | | | |
| Cardiac | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | | | | | | | | |
| Other (Specify) | | | | | | | | |

N - new indication; P -- previously cleared by 14DA, E - added under this appendix Additional comments: Combined mode: B+M

(II) FASH DO NOT WRITE BFF OW THIS LINE - CONTINUE ON ANDITIER PAGE IT NEEDED) Concurrence of CDRH, Office of Device Evaluation (UDI:)

Prescription Use (Per 21 CFR 801.109)

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

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## Diagnostic Ultrasound Indications for Use Form

### DUS 3 with L741 Transduccr

Intended Use: Diagnostic ultrasound imaging or thuid flow annilysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | N | N | | | | N | |
| Neonatal Cephalic | N | N | | | | N | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | | | | N | |
| Musculo-skeletal (Superficial) | N | N | | | | N | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | |
| Other (Specify) | | | | | | | |

N - new indication: P - previously cleared by FDA: F: = added under this appendix Additional comments Combined mode: B-M

(PLEASE DO NOT WRITE MI,JOW THIS I INC. - CONTINUE ON ANOTHER PAGE IF NELIA.D) Concurrence of CDRH, Office of Device Evaluation (ODI:)

Prescription Usc (Per 21 CFR 801.109)

2-5 Page 5 of 13

hryu Khhan

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

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い

## Diagnostic Ultrasound Indicatious for Use Form

#### DUS 3 with E741 Transducer_

Intended Use: Diagnostic ultrasomd imaging or thaid flow analysis of the human bridy as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N = new indication: P = previously cicared by I'DA: E = added under this appendix Additional comments: Combined mode: B+M

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(PLA.ASL DO NOT WRED! MELOW TINS LINE - CONTINUE ON AND HER PAGE IF NEEDED) Concurrence of CDRH, Offsee of Device Evaluation (ODE)

Preseription Use (Per 21 CFR 801.109)

2-6 Page 6 of 13

Hori In Khan

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

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## Diagnostic Ultrasound Indications for Use Form

### DUS 3 with E611-1 Transducer

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

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N - new indication; ( > previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M

(PLEASE DO NOT WRITE MELOW THIS LINE - CONTINUE ON ANGTRER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/10/Picture/7 description: The image contains the text "Prescription Use (Per 21 CFR 801.109)". The text is centered and appears to be part of a label or instruction. The text is enclosed in an oval shape.

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Aogu th why
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number_

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### Diagnostic Ultrasound Indications for Use Form

#### DUS 6 Digital Ultrasonic Diagnostic Imaging System

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|--|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | | |
| Abdominal | N | N | | | | N | | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | N | | |
| Small Organ (Specify) | N | N | | | | N | | |
| Neonatal Cephalic | N | N | | | | N | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | N | N | | | | N | | |
| Transvaginal | N | N | | | | N | | |
| Transurethral | | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | | | | N | | |
| Musculo-skeletal (Superficial) | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Other (Specify) | | | | | | | | |
| Cardiac | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | N | N | | | | N | | |
| Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by #DA: L = added under this appendix

Additional comments: Combined mode: BTM

(04)EAST DO NOT WRITE BLLOW THIS LINE - CONTINUL ON ANDFULTIT PAGE II' NELLIED) Concurrence of CDRH, Office of Device Evidention (ODI)

Preseription Use (Per 21 CFR 801.199)

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Aoru In why

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number.

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ે

.

## Diagnostic Ultrasound Indications for Use Form

#### DUS 6 with C363-1 / C343-1 Transducer

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

| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
|---------------------------------|---|---|-----|-----|---------------|--------------------|------------------|
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N - new indication, P previously cleared by FDA; I: = added under this appendix Additional comments: Combined mode: B + M

(PLEASE DO NOT WRITE BELOW THIS I INC - CONTINUE ON AND THER PAGE IF NEADED) Concurrence of CDRU, Otfice of Device Evaluation (ODE)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Per 21 CFR 801.109)

2-9

Page 9 of 13

tom Whang

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

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

## Diagnostic Ultrasound Indications for Use Form

### DUS 6 with C321 Transducer

Intended Use: Diagnostic ultrasound invaging or thaid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|--|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | |
| Abdominal | N | N | | | | N | | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | N | | |
| Small Organ (Specify) | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | |
| Intravascular | | | | | | | | |
| Other (Specify) | | | | | | | | |
| Cardiac | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | | | | | | | | |
| Other (Specify) | | | | | | | | |

No new indication: P previously cleared by IDA: L' added under this appendix Additional comments: Combined mode: B+M

(IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AND THER PAGE IF AFF-DED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/13/Picture/7 description: The image contains the text 'Prescription Use (Per 21 CFR 801 109)'. The text is written in a simple, sans-serif font. The text is likely part of a document or label related to prescription medication or medical devices, referencing the Code of Federal Regulations (CFR) for regulatory compliance.

. .

2-10 Page 10 of 13

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

**510(k) Number**

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

## Diagnostic Ultrasound Indications for Use Form

### DUS 6 with L743 Transducer

Intended Use: Diagnostie ultrasound imaging or fluid How analysis of the human body as lollaws:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | N | N | | | | N | |
| Neonatal Cephalic | N | N | | | | N | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | | | | N | |
| Musculo-skeletal (Superficial) | N | N | | | | N | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | |
| Other (Specify) | | | | | | | |

N = new indication: I' = previously cleared by I'DA: E = added under this appendix Additional comments: Combined mode: B | M

(H.CASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDITIER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODL)

Preseription f.!se (Per 21 CFR 801 109)

1

2-11 Page 11 of 13

tony M. Whg

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

{15}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

## DUS 6 with E743 Transducer_

Intended Use: Diagnostic ultrasing or Huid How analysis of the human body as follows:

| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
|---------------------------------|---|---|-----|-----|---------------|--------------------|------------------|
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N = new indication; 11 = previously cleared by PDA: L = added under this appendix Additional comments: Combiued mode: 13+M

(PLEASE DO NOT WRITI, BELOW THES LINE - CONTINUE ON ANGTITIFIC PAGE IF NEFEDED) Concurrence of CDRH, Office of Device F.valuation (ODE)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. Prescription Use (Per 21 CFR 801,109)

> 2-12 Page 12 of 13

Tomi Th wh

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

**510(k) Number** ***_***

{16}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

### DUS 6 with E613 Transducer

Intended Use: Diagnostic ultrasound imaging or third flow analysis of the human hudy as follows:

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
|---------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Specify) | | | | | | | |

N = new indivation: P = previously cleased by FFA: E = added under this appendix Additional comments: Combined mode: 13 FM

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUT DN ANOTHER PAGE IF NEELDED) Concurrence of CDR11, Office of Device Evaluation (ODF.)

Prescription Use (Per 2) Click 801.109) (800)

2-13 Page 13 of 13 .

Aram Whaz

(Division Sign-Off) (Division Sign-Ont)
Division of Reproductive, Abdominal, Divisioniogical Devices

-

510(k) Number