UF-760AG
Device Facts
| Record ID | K110920 |
|---|---|
| Device Name | UF-760AG |
| Applicant | Fukuda Denshi Co., Ltd. |
| Product Code | ITX · Radiology |
| Decision Date | Apr 8, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal. Transesophageal (Cardiac), Peripheral vascular. The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D, harmonic imaging), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color Time Motion (CM).
Device Story
Portable ultrasound system (14.5"x14.4"x3.9") with 15" TFT screen, keyboard, and transducers. Inputs: ultrasonic signals via transducers. Processing: B-mode, 3D/4D, M-mode, PW/CW Doppler, Color Flow Mapping, Color Time Motion, and harmonic imaging. Output: real-time diagnostic images and flow analysis displayed on screen; supports image storage and hard-copy. Used in clinical settings by qualified physicians. Output assists in diagnostic investigations and clinical decision-making for various anatomical regions and patient populations.
Clinical Evidence
Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. Conformance to IEC 60601-1, IEC 60601-2-37, ISO 10993-1, and other standards was verified. No clinical data was required as the device uses the same technology and principles as existing cleared devices.
Technological Characteristics
Portable ultrasound system with 15" TFT display. Modes: B-mode, 3D/4D, M-mode, PW/CW Doppler, CFM, CM, harmonic imaging, and Power Doppler Tissue Imaging. Transducers: FUT-SA162-5P, FUT-3-8 PA, FUT-3-8TEM, FUT-LA385-12P, FUT-5-12L50, FUT-CA602-5P, FUT-CVA403-6A, FUT-TVG114-7A, FUT-PEN2. Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-37, IEC 62304, ISO 10993-1, ISO 14971, AIUM AOMS-2004, and AIUM RTD1-2004.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal/obstetric, gynecological, abdominal, small organ (thyroid, breast, testes), adult cephalic, trans-cranial, musculoskeletal, cardiac (adult/pediatric/fetal), transesophageal, and peripheral vascular applications.
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
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for Fukuda Denshi, a Japanese medical equipment manufacturer. The logo consists of a stylized letter "F" on the left, followed by the company name in bold, sans-serif font. Below the company name, there is a handwritten alphanumeric string "K110920".
## Summary of Safetv and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c)
APR - 8 2011
- 1. Submitter Information
| a. | Submitter: | Fukuda Denshi Co. Ltd.<br>39-4 Hongo 3-chome, Bunkyo-ku<br>Tokyo 113-8420<br>Japan |
|----|------------|------------------------------------------------------------------------------------|
|----|------------|------------------------------------------------------------------------------------|
- b. Contact Person: Mr. Loran Van Noy Fukuda Denshi USA INC. 17725 N.E. 65th Street Bldg. C Redmond, WA 98052-4911 Phone:425-881-7737 Fax: 425-869-2018
- c. Date Prepared: 10 February 2011
- 2. Name of device
- a. Trade name: UF-760AG
- b. Common name: Medical Diagnostic Ultrasound Imaging System and transducers
- c. Classification: Class II
- d. Classification name: Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560 90-IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX
- 3. Equivalent Legally-Marketed Devices:
Fukuda Denshi UF-870AG (K081919)
GE, Voluson 730 (K003525, K032620 and K041688)
The technological characteristics of the predicate device are the same as those of the new device.
- 4. Description
The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time Motion (CM).
The submission also includes the transducers necessary for these procedures.
The system is a portable unit approximately 14.5" wide, 14.4" deep and 3.9" high equipped with a keyboard control panel, a 15" TFT screen, assorted transducers and image storage or hard-copy devices.
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Image /page/1/Picture/1 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' and 'DENSHI' stacked on top of each other. The logo is black and white and has a bold, blocky font.
#### 5. Intended use
Diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time Motion (CM).
- 6. Performance Data
- a. Non-clinical tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- · IEC 60601-1
- · IEC 60601-1-1
- · IEC 60601-1-2
- · IEC 60601-1-4
- · IEC 60601-2-37
- · IEC 62304
- · ISO 10993-1
- · ISO 14971
- · AIUM AOMS-2004
- · AIUM RTD1-2004
Cleared patient contact materials, electrical and mechanical safety are unchanged.
The following quality assurance measures were applied to the development of the system:
- · Risk Analysis
- · Requirement Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Final acceptance testing (Validation)
- · Performance testing (Verification)
- · Safety Testing (Verification)
- b. Clinical tests: Since the UF-760AG uses the same technology and principles as existing devices, clinical tests are not required.
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Image /page/2/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left and the words "FUKUDA" and "DENSHI" stacked on top of each other on the right. The logo is black and white.
- c. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Ouality System Regulation and ISO13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Fukuda Denshi that the UF-760AG is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with the head and torso formed by curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Fukuda Denshi Co., Ltd % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
#### APR - 8 2011
Re: K110920
Trade/Device Name: Fukuda Denshi Diagnostic Ultrasound System UF-760AG Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 31, 2011 Received: April 1, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Fukuda Denshi Diagnostic Ultrasound System UF-760AG, as described in your premarket notification:
#### Transducer Model Number
FUT-SA162-5P FUT-3-8 PA FUT-3-8TEM FUT-LA385-12P FUT-5-12L50
FUT-CA602-5P FUT-CVA403-6A FUT-TVG114-7A FUT-PEN2
{4}------------------------------------------------
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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely Yours,
Mary Shustef
Mary s. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Image /page/5/Picture/1 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" and "DENSHI" stacked on top of each other. The logo is in black and white.
# Indications For Use Form
510(k) Number (If known)
Device Name:
Fukuda Denshi Diagnostic Ultrasound System UF-760AG
Indications for Use:
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal. Transesophageal (Cardiac), Peripheral vascular.
The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D/4D, harmonic imaging), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color Time Motion (CM)
| Prescription Use | X | AND/OR |
|-----------------------------|---|--------|
| (Part 21 CFR 801 Subpart D) | | |
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Slatte
(Division Sign-Off)
Division of Radiological D Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110926
10 February 2011
ﺴﺘﻌ
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Image /page/6/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left and the words "FUKUDA" and "DENSHI" stacked on top of each other on the right. The logo is black and white and has a simple, modern design.
#### Diagnostic Ultrasound Indications for Use Form
#### System: UF-760AG diagnostic ultrasound system
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-------------------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| | Fetal Imaging & Other | Ophthalmic | | | | | | |
| Fetal | | P | P | P | | P | P | [3],[4],[5],[7] |
| Abdominal | | P | P | P | | P | P | [3],[4],[5],[7] |
| Intraoperative (specify) | | | | | | | | |
| Intraoperative (Neurological) | | | | | | | | |
| Laparascopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organs[2] | | P | P | P | P | P | P | [3],[5],[7] |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | [3],[5],[7] |
| Cardiac | Transrectal | | | | | | | |
| | Transvaginal | P | P | P | P | P | P | [3],[5],[7] |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | [3],[5],[7] |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | [3],[5],[7] |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | [3],[5],[6],[7] |
| | Cardiac Pediatric | P | P | P | P | P | P | [3],[6] |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | P | P | P | P | P | P | [6] |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | P | P | P | P | P | P | |
| | Peripheral Vessel | P | P | P | P | P | P | [3],[4],[5],[7] |
| | Other (specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
(3) Harmonic Imaging
[4] 3D/4D
- [5] Power Doppler
- [6] Doppler Tissue Imaging
- [7] Imaging for guidance of biopsy
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)
(Division Sian-Off
Division of Radiological Devices
agnostic Device Evaluation and Safety
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S/Patel
Office of In Vitro D
510K
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Image /page/7/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized triangle 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.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-SA162-5P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-----------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| Fetal Imaging & Other | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | [3],[5],[7] |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | [3],[6],[7] |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | P | P | P | P | P | P | [3],[5],[7] |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
- [3] Harmonic Imaging
- [5] Power Doppler
- [6] Doppler Tissue Imaging
[7] Imaging for guidance of biopsy
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIV
Office of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Slade
Prescription Use (Per 21 CFR 801.109)
**UF-760AG, V01-0x : 510(k) Submission**
Edition 2 .
(Division Sign-Off)
Division of Radiological Device
Office of In Vitro Diagnostic Device Evalua
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left and the words "FUKUDA DENSHI" on the right. The letter "F" is made up of two triangles, one on top of the other. The words "FUKUDA DENSHI" are in a bold, sans-serif font.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-3-8 PA
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<br>Doppler | Combined[1] | Other<br>(specify) |
| Fetal Imaging & Other | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | [3],[6] |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | | | | | | | |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[3] Harmonic Imaging
[6] Doppler Tissue Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Dey
scription Use (Per 21 CFR 801.109)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
**UF-760AG, V01-0x : 510(k) Submission**
Edition 2
10 February 2011
SION
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Image /page/9/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized triangle on the left and the words "FUKUDA" and "DENSHI" stacked on top of each other on the right. The logo is black and white.
### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-3-8TEM
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-----------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| Fetal Imaging & Other | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | P | P | P | P | P | P | [6] |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | | | | | | | |
| | Other (specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[6] Doppler Tissue Imaging
| Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD) | Prescription Use (Per 21 CFR 801.109) |
|------------------------------------------------------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Radiological Devices |
| | Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K110920 |
{10}------------------------------------------------
Image /page/10/Picture/1 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" and "DENSHI" stacked on top of each other. The logo is black and white.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-LA385-12P
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<br>Doppler | Combined[1] | Other<br>(specify) |
| Fetal Imaging & Other | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | P | P | P | P | P | P | [3],[5],[7] |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | [3],[5],[7] |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | [3],[5],[7] |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | P | P | P | P | P | P | [3],[5],[7] |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
(3) Harmonic Imaging
[5] Power Doppler
[7] Imaging for guidance of biopsy
Concurrence of CDRH, Office of In Vitro Diagnostic Devices
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
571918
801.109)
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized triangle on the left and the words "FUKUDA DENSHI" on the right. The word "FUKUDA" is on top of the word "DENSHI". The logo is in black and white.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-5-12L50
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-----------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| Fetal Imaging & Other | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | P | P | P | P | P | P | [3],[5],[7] |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | [3],[5],[7] |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | [3],[5],[7] |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | P | P | P | P | P | P | [3],[5],[7] |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[3] Harmonic Imaging
[5] Power Doppler
[7] Imaging for guidance of biopsy
y Stot
(Division SignPostscription Use (Per 21 CFR 801.109)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OTVD)
Division of Radiological Devices
of In Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Se
510K K110920
10 February 2011
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left and the words "FUKUDA DENSHI" on the right. The letter "F" is made up of two triangles, one inside the other. The words "FUKUDA DENSHI" are in a bold, sans-serif font.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
#### Transducer: FUT-CA602-5P
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<br>Doppler | Combined[1] | Other<br>(specify) |
| Ophthalmic | Fetal | P | P | P | P | P | P | [3],[5],[7] |
| | Abdominal | P | P | P | P | P | P | [3],[5],[7] |
| Fetal Imaging & Other | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | [3],[5],[7] |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[3] Harmonic Imaging
[5] Power Doppler
[7] Imaging for guidance of biopsy
M. Scott
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In
510K. K110920
se (Per 21 CFR 801.109)
{13}------------------------------------------------
Image /page/13/Picture/1 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" and "DENSHI" stacked on top of each other. The logo is in black and white.
#### Diagnostic Ultrasound Indications for Use Form
#### System: UF-760AG
#### Transducer: FUT-CVA403-6A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-----------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | N | N | N | [3],[4],[5] |
| | Abdominal | N | N | N | N | N | N | [3],[4],[5] |
| Fetal Imaging & Other | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | N | N | N | N | N | N | [3],[4],[5] |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[3] Harmonic Imaging
[4] 3D/4D
[5] Power Doppler
Concurrence of CDRH, Office of Device Evaluation (C
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
ETOK
cription Use (Per 21 CFR 801.109)
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left and the words "FUKUDA DENSHI" on the right. The letter "F" is made up of two triangles, one on top of the other. The words "FUKUDA DENSHI" are in a bold, sans-serif font.
#### Diagnostic Ultrasound Indications for Use Form
System: UF-760AG
### Transducer: FUT-TVG114-7A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | |
|-----------------------|-------------------------------|-------------------|---|-----|-----|------------------|-------------|--------------------|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined[1] | Other<br>(specify) |
| | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | [3],[5],[7] |
| Fetal Imaging & Other | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs [2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | P | P | P | P | P | P | [3],[5],[7] |
| Cardiac | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| | Peripheral Vessel | | | | | | | |
| | Other (specify) | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
[3] Harmonic Imaging
[5] Power Doppler
[7] Imaging for guidance of biopsy
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD
VDY
Description for use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
210K
{15}------------------------------------------------
Image /page/15/Picture/1 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized triangle on the left and the words "FUKUDA" and "DENSHI" stacked on top of each other on the right. The triangle is made up of three horizontal lines, with the top and bottom lines being shorter than the middle line.
#### Diagnostic Ultrasound Indications for Use Form
#### System: UF-760AG
#### Transducer: FUT-PEN2
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<br>Doppler | Combined[1] | Other<br>(specify) |
| Ophthalmic | | | | | | | | |
| Fetal Imaging & Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify) | | | | | | | |
| | Intraoperative (Neurological) | | | | | | | |
| | Laparascopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organs[2] | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Transrectal | | | | | | | |
| | Transvaginal | | | | | | | |
| | Transurethral | | | | | | | |
| | Transesophageal (non Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | P | P | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Transesophageal (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral Vessel | | | | | | | | |
| Other (specify) | | | | | | | | |
N= new indication; P= previously cleared by FDA (K081919); E= added under this appendix Notes:
[1] Combined modes are B+M, B+PWD (or CWD), B+Color+M, B+Color+PWD (or CWD)
[2] Small organs includes thyroid, breast and testicle
Concurrence of CDRH, Office of In Vitro Diagg escription Use (Per 21 CFR 801.109) Office of In Vitro
510K K110920
10 February 2011
