FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER

K990401 · Fukuda Denshi USA, Inc. · IYO · Oct 15, 1999 · Radiology

Device Facts

• Record ID: K990401
• Device Name: FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER
• Applicant: Fukuda Denshi USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use 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

Portable general-purpose ultrasound scanning system (UF-5800A) with optional Doppler unit (UF-5800DU). Projects ultrasound waves into body tissue; processes returned echoes to generate 16-level grayscale or black-and-white images. Supports M-mode, B-mode, and Doppler (CW/pulsed) modes. Operated by physicians or qualified healthcare professionals in clinical/hospital settings (ER, ICU, CCU, OR). Includes built-in measurement and calculation packages for clinical assessment. Output displayed on 7-inch monitor for real-time visualization of anatomy and blood flow. Assists clinicians in diagnostic imaging and fluid flow analysis, supporting clinical decision-making across various patient populations.

Clinical Evidence

Bench testing only. Validation included environmental testing per FDA 1993 guidance, compliance with NEMA/AIUM acoustic output standards (1992), and ANSI/AAMI ES1-1993 safe current limits. Biocompatibility and thermal requirements verified. Hazard analysis and system operation verification performed.

Technological Characteristics

Microprocessor-controlled ultrasound system. Probes: linear, convex, sector, and CW Doppler. Display: 7-inch diagonal video monitor. Connectivity: standalone. Biocompatible patient-contact materials. Acoustic output meets Track 1 limits. Software-controlled operation.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intraoperative (abdominal/periphery), pediatric, small organ (thyroid, breast, testes), cardiac, transrectal, transvaginal, and peripheral vessel applications. For use on neonate, pediatric, and adult patients. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• FUKUDA DENSHI FF sonic model UF-4500 (K922208)
• FUKUDA DENSHI FF sonic model UF-3500 (K955543)
• Medison model SonoAce 4800 (K925582)

Submission Summary (Full Text)

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

K990401

OCT 1 5 1999

# 510(k) Summarv Fukuda Denshi FF sonic model UF-5800A

General Purpose Ultrasound Scanner with Doppler (UF-5800DU)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR part 807.92.

## Submitter:

FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 Tel: [phone] Fax: [phone]

### Contact Person:

David J. Geraghtv Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 Tel: [phone] Fax: [phone]

Date Prepared:

January 20, 1998

## Device Name:

Proprietary Name:

Fukuda Denshi FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU)

### Common Name:

General Purpose Ultrasound Scanner with Doppler Option

### Classification Name:

Ultrasonic Pulsed Doppler Imaging System (§892.1550) Ultrasonic Pulsed Echo Imaging System (§892.1560) Diagnostic Ultrasonic Transducer (§892.1560)

# Legally Marketed Device:

- FUKUDA DENSHI FF sonic model UF-4500 General ● Purpose Ultrasound Scanner (K922208)
- FUKUDA DENSHI FF sonic model UF-3500 General . Purpose Ultrasound Scanner (K955543)
- Medison model SonoAce 4800 (K925582) .

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

# Description:

The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A

This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.

# Intended Use:

This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use 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.

UF-5800 510(k) Submission 510(k) Summary.doc

January 20, 1998 Page 2 of S 4

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# Technological Characteristics

The UF-5800 incorporates a microprocessor in the same manner as the predicate devices. The linear and convex, probes, the same probes available for the Fukuda Denshi predicate device, are applicable to the UF-5800A. The UF-5800A will accept sector probes and, with the Doppler option, the CW Doppler probe in a manner similar to the Medison SonoAce 4800 predicate device. Patient contact materials are biocompatable and identical to the predicate Fukuda Denshi devices.

The technological characteristics do not raise new issues with the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate devices and are addressed in the system's hazard analysis and in the system validation.

The device's derated acoustic output limits are below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997, and restated below:

| Use | ISPTA3<br>(Mw/CM²) | ISPTA3<br>(Mw/CM²) | MI |
|------------------------|--------------------|--------------------|------|
| Peripheral Vessel | 720 | 190 | 1.9 |
| Cardiac | 430 | 190 | 1.9 |
| Fetal Imaging & Other* | 94 | 190 | 1.9 |
| Ophthalmic | 17 | 28 | 0.23 |

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# Testing:

Laboratory testing was conducted to validate and verify the FUKUDA DENSHI FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU) met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800. This testing consisted of the environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary NEMA/AIUM "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment," 1992 and ANSI/AAMI ES1-1993, "safe current limits for electromedical apparatus." Patient contact surfaces were confirmed to be biocompatable and met thermal requirements. Finally, a hazard analysis of the system and its software was performed and testing was conducted to verify the systems overall operation.

# Conclusion:

The conclusions drawn from the testing of the FUKUDA DENSHI FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU) demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, the FUKUDA DENSHI models UF-4500 (K92208) and UF-3500 (K955543) or the Medison SonoAce 4800 (K925582).

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

Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a bird or a ribbon.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Fukuda Denshi America Corporation c/o Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blv. Suite 200 Great Neck, NY 11021

Re: K990401

Trade Name: Fukuda Denshi FF sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler Regulatory Class: II

21CFR892.1550/Procode: 90 IYN 21CFR892.1560/Procode: 90 IYO 21CFR892.1570/Procode: 90 ITX Dated: August 12, 1999 Received: August 16, 1999

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) 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 sonic UF-5800 General Purpose Ultrasound Scanning System, as described in your premarket notification:

#### Transducer Model Number

### FUT-L104, FUT-L106, FUT-C111, FUT-TV36-5, FUT-TR31-5, FUT-io07, FUT-io10, FUT-io17, FUT-SM181-35A, FUT-SM121-50A, FUT-SM201-25A, FUT-ID121-25A,

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Ms. Susan D. Goldstein-Falk

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Paul M. Gammell, Ph.D. at [phone].

Sincerely vours.

Thos A. Segman

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

510(k) Number (if known):

Attachment #1

## EXHIBIT D

### (Revised)

#### Ultrasound Device Indications Statement

Fill out one form for each ultrasound system or transducer

4990401

Device Name:

Fukuda Denshi model UF-5800 System

---

Indications for 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | B/M | |
| Abdominal | | N | N | | | | | | B/M | |
| Intraoperative (Specify) | | N | N | | | | | | B/M | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | N | N | | N | | | | B/M/D | |
| Small Organ (Specify) | | N | N | | | | | | B/M | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | | | | B/M/D | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | | | | | | B/M | |
| Transvaginal | | N | N | | | | | | B/M | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | N | N | N | | | | | B/M/D | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | N | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | N | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Other Indication or Modes:

Small Organ is defined as thyroid, breast, and testes.

Intraonerative is defined as the abdominal region and the periphery.

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

David A. Seaman

Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Indications Statement revised

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

K990401

Fill out one form for each ultrasound system or transducer

#### Fukuda Denshi model UF-5800A w/ FUT-L104 Probe Device Name:

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

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

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

Other Indication or Modes:

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

David A. Leggett

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

510(k) Number K990401

UF-5800 510(k) Submission Special Report REV B.doc

Prescription Use (Per 21 CFR 801.109) August 25, 1997

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

K990401

Fill out one form for each ultrasound system or transducer .

#### Fukuda Denshi model UF-5800A w/ FUT-L106 Probe Device Name:

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

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

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

---

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

Small Organ is defined as thyroid, breast, and testes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Bergman

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990401

Other Indication or Modes:

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

# K 990401

### Ultrasound Device Intended Use Form

Fill out one form for each ultrasound system or transducer

#### Fukuda Denshi model UF-5800A w/ FUT-C111 Probe 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) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | B/M | |
| Abdominal | | N | N | | | | • | | B/M | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

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

Other Indication or Modes:

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

Concurrence of CPRH, Office of Device Evaluation (ODE)

Yamil C. Leyva
(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K992401

(Prescription Use (Per 21 CRF 801.109)

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

Fill out one form for each ultrasound system or transducer

Fukuda Denshi model UF-5800A w/ FUT-TV36-5 Probe Device Name:

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

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

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

Other Indication or Modes:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oavid A. Sezenn
(Division Sign-Off)

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

Prescription Use (Per 21 CRF 801.109)

Page: 9 of 16

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

Fill out one form for each ultrasound system or transducer

#### Fukuda Denshi model UF-5800A w/ FUT-TR31-5 Probe Device Name:

Intended Use: Diagnostic ultrasound imaging or fluid Small Organ is defined as thyroid, breast, and testes 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) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | • | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | | | | | | B/M | |
| Transvaginal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

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

Other Indication or Modes:.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990401

Prescription Use (Pep 21 CRF 801.109)

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

# K990401

### Ultrasound Device Intended Use Form

Fill out one form for each ultrasound system or transducer

#### Device Name: Fukuda Denshi model UF-5800A w/ FUT-1007 Probe

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

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

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

Other Indication or Modes:

Intraoperative is defined as the abdominal region and the periphery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seggern

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

Prescription Use (Per 21 CRF 801.109)

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

99,040

Fill out one form for each ultrasound system or transducer

#### Fukuda Denshi model UF-5800A w/ FUT-IO03 Probe Device Name:

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

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

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

Other Indication or Modes.

Intraoperative is defined as the abdominal region and the periphery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Severson

(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CRF 801.109)

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

# 990401

### Ultrasound Device Intended Use Form

Fill out one form for each ultrasound system or transducer

#### Fukuda Denshi model UF-5800A w/ FUT-IO10 Probe Device Name:

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

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

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

Other Indication or Modes: Intraoperative is defined as the abdominal region and the periphery. Small Organ is defined as thyroid, breast, and testes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman

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

Prescription Use (Per 21 CRF 801.109)

Page: 14 of 16

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

K990401

Fill out one form for each ultrasound system or transducer

#### Device Name: Fukuda Denshi model UF-5800A w/ FUT-IO17 Probe

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

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

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

Other Indication or Modes: Intraoperative is defined as the abdominal region and the periphery Small Organ is defined as thyroid, breast, and testes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Szymm

on Sign-Off) Division of Reproductive, Abdominal, ENT, iological Device

Prescription Use (Per 21 CRF 801.109)

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

### EXHIBIT D

### (Revised)

### Ultrasound Device Indications Statement

Fill out one form for each ultrasound system or transducer

|<990401

510(k) Number (if known): Device Name:

1.33.1

**Device Name:**

1. b. 1.

Fukuda Denshi model UF-5800 w/ FUT-SM181-35A Probe

Indications for 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) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | B/M | |
| Abdominal | | N | N | | | | | | B/M | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | | | | B/M/D | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

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

Other Indication or Modes:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segerson

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

Prescription Use
(Per 21 CFR 801.109)

Indications Statement revised

{17}------------------------------------------------

### EXHIBIT D (Revised)

### Ultrasound Device Indications Statement

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

K990401 510(k) Number (if known):

Device Name:

Fukuda Denshi model UF-5800 w/ FUT-SM121-50A Probe

Indications for 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) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | B/M | |
| Abdominal | | N | N | | | | | | B/M | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | B/M | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | | | | B/M/D | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | N | N | N | | | | | B/M/D | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

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

Other Indication or Modes:

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

David A. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number JC990

Prescription Use (Per 21 CFR 801.109)

2

Indications Statement revised

{18}------------------------------------------------

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

#### Fukuda Denshi model UF-5800A w/ UF-5800DU and Device Name: FUT-SM201-25A Probe

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