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)

Device 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.

AI/ML Overview

The provided text is a 510(k) summary for the Fukuda Denshi UF-760AG Diagnostic Ultrasound Imaging System. It describes the device, its intended use, and states that clinical tests were not required because the device uses the same technology and principles as existing predicate devices. Therefore, there is no study provided that proves the device meets specific acceptance criteria based on clinical performance.

The document focuses on demonstrating substantial equivalence to already cleared devices based on non-clinical performance and technological characteristics.

Here's an attempt to answer your questions based solely on the information available in the provided text, acknowledging the absence of a clinical performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific quantitative acceptance criteria or clinical performance metrics are provided, this table cannot be fully populated as you requested for a device performance study. The "performance" described is largely about compliance with safety standards and the device's functional modes.

Category	Acceptance Criteria	Reported Device Performance
Non-clinical Performance	Compliance with applicable medical device safety standards.	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety. It conforms with: 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 development process applied: 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).
Clinical Performance / Effectiveness	(Implied: To be as safe and effective as predicate devices.)	Clinical tests were not required as the UF-760AG uses the same technology and principles as existing devices. The intent is that it performs comparably to the predicate device, Fukuda Denshi UF-870AG (K081919) and GE, Voluson 730 (K003525, K032620, K041688). The device is intended for diagnostic ultrasound investigations including: 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) across various clinical applications (Fetal/Obstetric, Gynecological, Abdominal, Small Organ, Adult Cephalic, Trans-cranial, Musculoskeletal, Cardiac-Adult/Pediatric/Fetal, Transesophageal, Peripheral vascular, Imaging for guidance of biopsy).
Quality Systems	Conformance with 21 CFR 820 Quality System Regulation and ISO13485:2003.	The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO13485:2003 quality system standards.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set data is described.
Data Provenance: Not applicable for clinical data. For non-clinical testing, the evaluations were conducted by Fukuda Denshi and independent evaluators. The country of origin for these analyses would be Japan (Fukuda Denshi's location) but is not explicitly stated for individual tests. The testing would be considered prospective for the device's development/verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical ground truth establishment is described due to the absence of clinical testing.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and thus no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was performed or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic diagnostic device, but a medical imaging system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. The "ground truth" for the non-clinical performance would be the specifications and requirements defined by the various safety and performance standards (e.g., meeting specific acoustic output limits, ensuring biocompatibility, electrical safety parameters).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for a device like this would involve design and engineering processes, validation against specifications, and quality controls without explicit data training sets.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reasons as point 8.

Summary

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

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.39-4 Hongo 3-chome, Bunkyo-kuTokyo 113-8420Japan
----	------------	------------------------------------------------------------------------------------

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
1. 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
1. 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.

1. 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.

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

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).

1. 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.

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

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.

{3}------------------------------------------------

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)

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

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:

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

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

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	ColorDoppler	Combined[1]	Other(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

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

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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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

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

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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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	ColorDoppler	Combined[1]	Other(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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.