Predicate Devices

K#033209

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and features.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging or fluid flow analysis," not for treatment.

Diagnostic

Yes

The "Device Description" explicitly states: "The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system." The "Intended Use / Indications for Use" section also specifies "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of two parts: the scanner and probes, which are hardware components. It also mentions an optional 3D imaging unit, also a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states the device is a "diagnostic ultrasound system." Its function is to "acquire and display ultrasound images" and perform "fluid flow analysis."
Method of Use: The device uses ultrasound waves applied externally to the body via probes to create images of internal structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Lack of Sample Analysis: There is no mention of the device analyzing biological samples taken from the patient.

The device is a diagnostic imaging system, which is a different category of medical device than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes, etc.), Cardiac, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial

Modes of Operation: B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (B/M/D/C), Harmonic Imaging, 3-D Imaging

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode).

The device consists of two parts: the scanner, and one of up to seven (7) different probes. In addition, the probe sclector unit provides two probes connection capability. The Fukuda Denshi Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, and musculoskeletal (general and superficial) exams.

This subject modified Ultrasound System also provides 3D imaging (Guided free hand 3D and Free hand 3D) with an optional 3D imaging unit (UF-750XT-3DU). New measurement functions have been added by the option 3D imaging unit (UF-750XT-3DU). No new transducers are being added and are not the subject of this submission.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, pediatric, small organ (thyroid, breast, testes, etc.), cardiac, transvaginal, peripheral vessel, musculo-skeletal (Conventional and Superficial)

Indicated Patient Age Range

neonate, pediatric, or adult

Intended User / Care Setting

competent health care professionals, physician or similarly qualified healthcare professional. Not intended for home use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Testing: Laboratory Testing:
Laboratory testing was conducted to verify that the Fukuda Denshi FF Sonic Model UF-750XT with option 3D imaging unit (UI-750XT-3DU) met all design specification and was substantially equivalent to the current legally marketed predicate devices. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility and effectiveness of cleaning and disinfection.

Clinical Test: No clinical testing was required

Conclusion: The conclusion drawn from the testing of the Fukuda Denshi FF Sonic Model UF-750XT Diagnostic Ultrasound system with option 3D imaging unit (UF-750XT-3DU) demonstrates that the device is as safe and effective as the current legally marketed predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K#033209

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

510(k) Summary

Fukuda Denshi Model FF Sonic UF-750XT Diagnostic Ultrasound System with option 3D imaging unit (UF-750XT-3DU)

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

The assigned 510(k) number is: KOB26 S6

Fukuda Denshi USA, Inc. Submitter: 17725 NE 65th Street, Building C Redmond, WA 98052 TEL: 425-881-7737 FAX: 425-869-2018
Contact Person: Loran Van Noy Senior Director Fukuda Denshi USA, Inc. 17725 NE 65th Street, Building C Redmond, WA 98052 TEL: 425-881-7737 FAX: 425-869-2018

Date Prepared: August 4, 2008

Device Name	Model Number
Fukuda Denshi Model FF Sonic UF-750XT
Diagnostic Ultrasound System	UF-750XT
3D imaging Unit	UF-750XT-3DU

General Purpose Ultrasound Scanner with Doppler Common Name:

Classification: Regulatory Class: II

Review Category: Tier II

	CFR Number	Product Code
Ultrasonic Pulsed Doppler Imaging
System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

1

Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the original Fukuda Denshi Diagnostic Ultrasound System that is already cleared under premarket notification number K#033209, and another predicate device noted below:

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Device Description: The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode).

The device consists of two parts: the scanner, and one of up to seven (7) different probes. In addition, the probe sclector unit provides two probes connection capability. The Fukuda Denshi Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, and musculoskeletal (general and superficial) exams.

This subject modified Ultrasound System also provides 3D imaging (Guided free hand 3D and Free hand 3D) with an optional 3D imaging unit (UF-750XT-3DU). New measurement functions have been added by the option 3D imaging unit (UF-750XT-3DU). No new transducers are being added and are not the subject of this submission.

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

Technological Characteristics:

The FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) incorporates the same fundamental technologies as the predicate devices. The

2

probes cleared with the predicate device (FF Sonic UF-750XT, K#033209) are used for the subject device. The device has been tested as Track 3 devices per the FDA guidance document "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers" issued in Scptember, 1997. The Acoustic Output is measured and calculated per NEMA UD 2 Acoustic Output Mcasurement Standard for Diagnostic Ultrasound Equipment: 2004. All transduccrs used with the FF Sonic UF-750XT are track 3 transducers and testing validated that no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0. All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device.

The technology characteristics of the FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) do not affect the safety or efficacy of the device. Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or arc addressed in the system hazard analysis or in the system validation.

Testing: Laboratory Testing:

Laboratory testing was conducted to verify that the Fukuda Denshi FF Sonic Model UF-750XT with option 3D imaging unit (UI-750XT-3DU) met all design specification and was substantially equivalent to the current legally marketed predicate devices. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility and effectiveness of cleaning and disinfection.

Applicable Standards:

The FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) conforms to the following Standards:

· NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004
NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices: 2004
IEC 60601-1 .
· IEC 60601-1-1
· IEC 60601-1-2
· IEC 60601-1-4
· IEC 60601-2-37

Clinical Test:

No clinical testing was required

Conclusion: The conclusion drawn from the testing of the Fukuda Denshi FF Sonic Model UF-750XT Diagnostic Ultrasound system with option 3D imaging unit (UF-

3

750XT-3DU) demonstrates that the device is as safe and effective as the current legally marketed predicate devices.

.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

SEP 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fukuda Denshi USA, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH PA 19462-1298

Re: K082656

Trade/Device Name: FFsonic UF-750XT Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYO Dated: September 11, 2008 Received: September 12, 2008

Dear Mr. Mosenkis:

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 FFsonic UF-750XT Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

FUT-CD602-5A FUT-CD602-5B FUT-CD505-8A FUT-LD386-9A FUT-CD152-5A

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FUT CD105-8A FUT-TVD114-7A

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 1 other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Device Name: FFsonic UF-750XT Diagnostic Ultrasound System

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

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

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Helene
(Division Sign-Off)

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

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

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

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

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler ( including Amplitude Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Herbert Lehman

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

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UF-750XT with FUT-CD602-5B Device Name:

| Clinical Application | A Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | Other
(Specify) |
|-----------------------|---|---|---| | Ophthalmic | | | | | Fetal | | P | P | P | | Abdominal | | P | P | P | | Intraoperative | | | | | Neurological | | | | | Pediatric | | | | | Small Organ (specify) | | | | | Neonatal Cephalic | | | | | Adult Cephalic | | | | | Cardiac | | | | | Transesophageal | | | | | Transrectal | | | | | Transvaginal | | | | | Intravascular | | | | | Peripheral Vessel | | | | | Laparoscopic | | | | | Musculo-skeletal | | | | | Conventional | | | | | Musculo-skeletal | | | | | Superficial | | | | | Other (specify) | | | | | B | M | PWD | CWD | Color
-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------|
| | | | | | | |
| P | P | P | B/M/D/C | P | |
| P | P | P | B/M/D/C | P | |
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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

Other Indications or Modes:

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

In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Helena

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

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	P	B/M/D/C	N
Abdominal		P	P	P		P	P	P	B/M/D/C	N
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P	P	B/M/D/C	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transcsophagcal
Transrectal
Transvaginal
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

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

Other Indications or Modes:

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

In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Helene

(Division 6 Division of Reproductive. Abdominal and Radiological Device 510(k) Number

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

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

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

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Hebert Leun

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

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UF-750XT with FUT-CD152-5A Device Namc:

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

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

Other Indications or Modes:

In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Vclocity Doppler ) In Other mode: 3-D Imaging ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Small Organ: brcast, thyroid, testes, etc. . . . . . .

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

Hubert Leever

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

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UF-750XT with FUT-CD105-8A 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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | Other
(Specify) |
|----------------------------|---|---------------------------------|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | B/M/D/C | | |
| Abdominal | | P | P | P | | P | P | P | B/M/D/C | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | B/M/D/C | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | B/M/D/C | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | | P | P | P | B/M/D/C | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N= new indication for use: | | D -- previously classed by EDA. | | | | | C - addad under Linnandia T | | | | |

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

Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Hubert Leem

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

13

Fill out one form for each ultrasound system or transducer

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

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

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

Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging

Small Organ: breast, thyroid, testes, etc.

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

Helenty Leem

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