FUKUDA DENSHI MODEL FF SONIC UF-750XT

K033209 · Fukuda Denshi USA, Inc. · IYN · Oct 31, 2003 · Radiology

Device Facts

• Record ID: K033209
• Device Name: FUKUDA DENSHI MODEL FF SONIC UF-750XT
• Applicant: Fukuda Denshi USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-750XT incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The FF sonic UF-750XT is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

Device Story

Compact, portable diagnostic ultrasound scanner; features fold-down keyboard, 10.4-inch TFT color LCD, and interchangeable convex/linear transducers. System performs data acquisition, processing, and display. Used in clinical settings by physicians or qualified healthcare professionals. Provides B-mode, M-mode, Pulse Wave Doppler (PWD), and Color Doppler (including Amplitude and Velocity) imaging. Built-in measurement and calculation packages assist clinicians in diagnostic assessment. Benefits include non-invasive visualization of internal structures and fluid flow, aiding clinical decision-making. Operates as a prescription-only device.

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by bench testing, including acoustic output measurements (NEMA UD 2, 1998), thermal/mechanical index validation (NEMA UD 3, 1998), and compliance with electrical/safety standards (IEC 60601-1-1, IEC 60601-1-2).

Technological Characteristics

Portable ultrasound system with 10.4-inch TFT LCD. Uses convex/linear transducers (Track 3). Acoustic output measured per NEMA UD 2:1998 and NEMA UD 3:1998. Biocompatible patient contact materials identical to predicate. Software-controlled system with integrated measurement/calculation packages. Complies with IEC 60601-1-1 and IEC 60601-1-2 safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (thyroid, breast, testes), cardiac (adult/pediatric), transvaginal, peripheral vessel, and musculo-skeletal (conventional/superficial) applications for neonate, pediatric, and adult patients. Prescription use only.

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

• Fukuda Denshi model FF sonic UF-5800 General Purpose Ultrasound Scanner with Doppler (K990401)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left, followed by the words "FUKUDA" on the top line and "DENSHI" on the bottom line. The text is in a bold, sans-serif font.

OCT 3 1 2003

# Fukuda Denshi Model FF sonic UF-750 XT Special 510(k) Device Modification

Exhibit B Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

The assigned 510(k) number is: K 033209

- Fukuda Denshi U.S.A. Inc. Submitter: 17725 NE 65th St. Building C Redmond. WA 98052 425-881-7737 Tel: [phone] Fax:
- Contact Person: Larry D. Walker Regulatory Affairs Manager Fukuda Denshi - Seattle Branch 17725 NE 65th St. Building C Redmond. WA 98052 425-881-7737 Tel: Fax: [phone]
- Date Prepared: September 29, 2003
- Fukuda Denshi model FF sonic UF-750 XT Diagnostic Ultrasound System Device Name:

Common Name General Purpose Ultrasound Scanner with Doppler

Ultrasound Pulse Doppler Imaging System, 21 CFR 892-1550, 90IYN Classification: Ultrasound Pulse Echo Imaging System, 21 CFR 892-1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892-1570, 90-ITX

Marketed Device: Fukuda Denshi model FF sonic UF-5800 General Purpose Ultrasound Scanner with Doppler, 510(k) No. K990401 currently in commercial distribution.

The Fukuda Denshi model FF sonic UF- 750XT is a compact and portable Device Description: general-purpose diagnostic ultrasound scanner with a fold down keyboard, integrated 10.4 inch TFT color LCD display and interchangeable convex and linear transducers. The system has physical dimensions 380 mm W X 220 mm D X 370 mm H in transport configuration. The system provides data acquisition, processing and display capabilities. User interfaces include the drop down computer type keyboard which includes specialized controls, Doppler audio and a color LCD display.

9/29/03

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# Fukuda Denshi Model FF sonic UF-750XT Special 510(k) Device Modification Exhibit B

## Intended Use: The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-750XT incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The FF sonic UF-750XT is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

## Technological Characteristics:

The FF sonic UF-750XT incorporates the same fundamental technology as the predicate device. All probes are modified version of the probes cleared with the predicate. The devices has been tested as a Track 3 devices per the guidance document:" Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers" Issued September 3000, 1997. The Acoustic Output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998. All transducers used with the UF-750XT are track 3 transducers and testing validated that no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0. All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device.

The technology characteristics of the FF sonic UF-750XT do not affect the safety or efficacy of the device. Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or are addressed in the system hazard analysis or in the system validation.

## Testing:

## Laboratory Testing:

Laboratory testing was conducted to verify that the Fukuda Denshi FF sonic model UF-750XT met all design specification and was substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility and effectiveness of cleaning and disinfection.

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

# Fukuda Denshi Model FF sonic UF-750XT Special 510(k) Device Modification

# Exhibit B

Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment (AUIM 1998)

# Applicable Standards

The Fukuda Denshi Model FF sonic UF-750XT conforms to the following Standards: NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998 NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices: 1998 IEC 60601-1-1 IEC 60601-1-2

# Clinical Test:

No clinical testing was required

Conclusion: The conclusion drawn from the testing of the Fukuda Denshi FF sonic model UF-750 XT Diagnostic Ultrasound system demonstrates that this device is as safe, as effective and performs as well or better than the current legally marketed predicate device, the Fukuda Denshi model UF-5800. (510(k) No. K990401)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

OCT 3 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Larry D. Walker Regulatory Affairs Manager Fukuda Denshi U.S.A., Inc. 17725 NE 65th St., Building C REDMOND WA 98052

Re: K033209

Trade Name: Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 30, 2003 Received: October 3, 2003

Dear Mr. Walker:

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 Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System, as described in your premarket notification:

## Transducer Model Number

| FUT-CD602-5A |
|--------------|
| FUT-CD505-8A |
| FUT-LD386-9A |

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# FUT-CD152-5A FUT-CD105-8A FUT-TVD114-7A

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer

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Page 3 – Mr. Walker

Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

David A. Lyon

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

Enclosure(s)

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### Fill out one form for each ultrasound system or transducer

#### FF sonic UF-750XT Diagnostic Ultrasound System Device Name:

| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | Mode of Operation | | | | | |
|----------------------------------|------------------------------------------------------------------------------------|---|---|-----|-------------------------------|-------------------|----------------------------|------------------------------|-----------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | P | P | N | | N | N | N | B/M/D/C | | |
| Small Organ<br>(Specify) | | P | P | N | | N | N | N | B/M/D/C | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | N | N | N | B/M/D/C | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | P | P | N | | N | N | N | B/M/D/C | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | N | N | N | B/M/D/C | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | N | | | | | | | |
| Musculo-skeletal<br>Superficial | | P | | N | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use; | | | | | P= previously cleared by FDA; | | E = added under Appendix E | | | | |

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

Small Organ is defined as thyroid, breast and testes. Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

*Prescription Use* ✓

1,000

David h. Glynn

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

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

### Fill out one form for each ultrasound system or transducer

#### UF-750XT with FUT-CD602-5A Device Name:

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

| | | | | | Mode | | of | Operation | | | |
|----------------------|---|---|---|-----|------|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

### Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

*Prescription Use* ✓

David A. Hayes

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

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

### Fill out one form for each ultrasound system or transducer

#### UF-750XT with FUT-CD505-8A Device Name:

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|-----------------|
| Mode of Operation | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | P | P | N | | N | N | N | B/M/D/C | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use; P= previously cleared by FDA; E = added under Appendix E | | | | | | | | | | | |

ostic ultrasound imaging or fluid flow analysis of the human body as follows:

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

______________________________________________________________________________________________________________________________________________________________________________

David A. Legum

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

*Prescription Use*

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

# Fill out one form for each ultrasound system or transducer

#### UF-750XT with FUT-LD386-9A Device Name:

| Clinical Application | A | B | M | PWD | CWD | Mode of Operation | | | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------|
| | | | | | | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | | | | B/M | | |
| Abdominal | | P | P | N | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | N | | N | N | N | B/M/D/C | | |
| Small Organ<br>(Specify) | | P | P | N | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | N | | N | N | N | B/M/D/C | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | | N | | | | | | | |
| Musculo-skeletal<br>Superficial | | P | | N | | | | | | | |
| Other (specify) | | | | | | | | | | | |

Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

David R. Lynn

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

Prescription Use

✓

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

### Fill out one form for each ultrasound system or transducer

#### UF-750XT with FUT-CD152-5A Device Name:

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|-------------------|---|---|-----|-------------------------------|---------------|-------------------|----------------------------|--------------------|------------------|-----------------|
| Clinical Application | Mode of Operation | | | | | | | | | | |
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) |
| Ophthalmic | | | | | | | | N | B/M/D/C | N | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | N | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | N | N | N | B/M/D/C | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use; | | | | | P= previously cleared by FDA; | | | E = added under Appendix E | | | |

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

David A. Segner

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

*Prescription Use* ✓

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

### Fill out one form for each ultrasound system or transducer

#### Device Name: UF-750XT with FUT-CD105-8A

| | | | | | Mode of Operation | | | | | | |
|-------------------------------------------------------------------------------------------|---|---|---|-----|-------------------|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | P | P | N | | N | N | N | B/M/D/C | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | N | N | N | B/M/D/C | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | N | N | N | B/M/D/C | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use:<br>P= previously cleared by FDA:<br>E = added under Appendix E | | | | | | | | | | | |

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)

V Prescription Use______________________________________________________________________________________________________________________________________________________________

David A. Seppam

(Division Sign-Off)

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

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

### Fill out one form for each ultrasound system or transducer

#### UF-750XT with FUT-TVD114-7A Device Name:

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

| | | | | | Mode of Operation | | | | | | |
|-------------------------------------------------------------------------------------|---|---|---|-----|-------------------|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | N | | N | N | N | B/M/D/C | | |
| Abdominal | | P | P | N | | N | N | N | B/M/D/C | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) | | P | P | N | | N | N | N | B/M/D/C | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | P | P | N | | N | N | N | B/M/D/C | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use; P= previously cleared by FDA; E = added under Appendix E | | | | | | | | | | | |

Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

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Prescription Use

David A. Layton

(Division Sign-Off)

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