Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the system using standard ultrasound technology components and signal processing.

Therapeutic

No
The device is clearly indicated for "diagnostic ultrasound evaluation" and described as an "ultrasound diagnostic system," with no mention of therapeutic applications.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation". Additionally, the "Device Description" refers to it as an "ultrasound diagnostic system".

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as ultrasound transducers, a computer system, and a video monitor, indicating it is a hardware-based ultrasound system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The Hitachi Aloka Medical, Ltd. Prosound F75 is an ultrasound diagnostic system. It uses ultrasound waves to create images of internal structures within the body (in vivo). It does not analyze specimens taken from the body.
Intended Use: The intended use clearly describes diagnostic ultrasound evaluation of various anatomical sites within the patient.
Device Description: The description focuses on transducers, computer systems for signal analysis, and image display, all consistent with an in vivo imaging device.

The information provided strongly indicates that this is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications.

The device is not indicated for Ophthalmic applications.

Product codes

IYN, IYO, ITX

Device Description

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected echoes
A video monitor with optional image recorder to display the computed image or derived Doppler data

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found.

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal; Abdominal; Intra-operative (neurosurgery, liver, pancreas, gall bladder); Pediatric; Small Organ (breast, testes, & thyroid); Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Neonatal; Cardiac Pediatric; Peripheral Vascular; Gynecological; Airways; Tracheobronchial tree; Gastrointestinal Tract and Surrounding Organs.

Indicated Patient Age Range

Not Found.

Intended User / Care Setting

Trained personnel (doctor, sonographer, etc.)

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)

Non-clinical Testing: No new hazards were identified with the addition of the added indications and software features. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required.

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

Not Found.

Predicate Device(s)

K123828

Reference Device(s)

K110673, K122537, K130058

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 03, 2015

Hitachi Aloka Medical, Ltd. % Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-7502

Re: K140639

Trade/Device Name: Prosound F75 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 11, 2014 Received: March 12, 2014

Dear Ms. Van Arsdale:

This letter corrects our substantially equivalent letter of April 16, 2014.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

1

This determination of substantial equivalence applies to the following transducers intended for use with the Prosound F75 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

ASU-1010	ASU-1012	ASU-1013	ASU-1014	UST-567	UST-675P
UST-677P	UST-678	UST-2265-2	UST-2266-5	UST-5293-5	UST-5296
UST-5411	UST-5415	UST-5417	UST-5418	UST-5419	UST-5713T
UST-9115-5	UST-9118	UST-9120	UST-9130	UST-9132I	UST-9132T
UST-9133	UST-9135P	UST-9146I	UST-9146T	UST-9147	UST-52105
UST-52110S	UST-52114P	UST-52119S	UST-52120S	UST-52121S	UST-52124
UST-52126	UST-52127	UST-52128	BF UC180F	GF UCT180F	GF UC140P-AL5
GF UCT140-AL5	UST-52127	GF UE160-AL5	UST-52128	TGF UC180J	BF UC180F

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

2

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jeffrey J. Ballyns -S Digitally signed by Jeffrey J. Ballyns -S DN: c=US. o=U.S. Government. ou=HHS FDA. ou=People 342.19200300.100.1.1=2000569725 ffrev J. Ballyns -S Date: 2015.03.03 14:51:22 -05'00

for

Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K140639

Device Name Prosound F75

Indications for Use (Describe)

The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications.

The device is not indicated for Ophthalmic applications.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Device Name: Hitachi Prosound F75

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Note 1
Fetal Imaging
& Other	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*	P	P	P		P	Note 1
	Intra-operative (Neurosurgery)	P	P	P		P	Note 1
	Laparoscopic**	N	N	N		N	Note 1
	Pediatric	P	P	P		P	Note 1
	Small Organ (Specify)*	P	P	P	P	P	Note 1
	Neonatal Cephalic	P	P	P		P	Note 1
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1
	Trans-vaginal	P	P	P		P	Note 1
	TEE (non-cardiac)	P	P	P		P	Note 1
	Trans-esoph. (non-Card.)	P	P	P		P	Note 1
	Musculo-skel. (Convent.)	P	P	P		P	Note 1
	Musculo-skel. (Superfic.)
	Other: (Specify) *	P	P	P		P	Note 1
	Other: Gynecological	P	P	P		P	Note 1
	Cardiac Adult	P	P	P	P	P	Note 1, 2
Cardiac	Cardiac Adult, TEE	P	P	P	P	P	Note 1, 2
	Cardiac - Neonatal	P	P	P	P	P	Note 1, 2
	Cardiac - Pediatric	P	P	P	P	P	Note 1, 2
	Cardiac - Pediatric, TEE	P	P	P	P	P	Note 1, 2
Peripheral
Vessel	Peripheral Vascular	P	P	P	P	P	Note 1, 2
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

*: Specification for "Other" Airways, Tracheobronchial tree, Gastrointestinal Tract and Surrounding Organs

Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )

** Laparoscopic indication for use cleared via K110673

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 2 of 45

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Device Name: PROSOUND F75

UST-567 Transducer:

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	P	P	P		P	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular	P	P	P	P	P	Note 1
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD * Applications: Small Organ-(breast, testes, & thyroid..)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 3 of 45

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Device Name: PROSOUND F75

UST-675P Transducer:

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1
	Trans-vaginal	P	P	P		P	Note 1
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE

Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)__

Page 4 of 45

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Device Name: PROSOUND F75 Transducer: UST-677P

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 5 of 45

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Device Name: PROSOUND F75 Transducer: UST-678

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 6 of 45

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Device Name: PROSOUND F75 Transducer: ASU-1010

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		P	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/PWD, B/CD, M/CD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 7 of 45

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Device Name: PROSOUND F75 Transducer: ASU-1012

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		N	Note 1
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		N	Note 1
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		N	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 8 of 45

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Device Name: PROSOUND F75 Transducer: ASU-1013

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

Clinical Application	Mode of Operation
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	P	P	P		N	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 9 of 45

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Device Name: PROSOUND F75 Transducer: UST-2265-2

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging	Abdominal
& Other	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult				P
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 10 of 45

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Device Name: PROSOUND F75 Transducer: UST-2266-5

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult				P
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular				P
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 11 of 45

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Device Name: PROSOUND F75 Transducer: UST-5293-5

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult	P	P	P	P	P	Note 1, 2
Cardiac	Cardiac Adult, TEE	P	P	P	P	P	Note 1, 2
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 12 of 45

15

Device Name: PROSOUND F75 Transducer: UST-5411

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	P	P	P	P	P	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular	P	P	P	P	P	Note 1
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

*Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)__

Page 13 of 45

16

Device Name: PROSOUND F75 Transducer: UST-5415

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging	Abdominal
& Other	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	P	P	P		P	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular	P	P	P		P	Note 1
Vessel	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD

Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)__

Page 14 of 45

17

Device Name: PROSOUND F75 Transducer: UST-5417

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	P	P	P		N	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular	P	P	P		N	Note 1
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD

Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 15 of 45

18

Device Name: PROSOUND F75 Transducer: UST-5419

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		N	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular	P	P	P		N	Note 1
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 16 of 45

19

Device Name: PROSOUND F75 Transducer: UST-5713T

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*	P	P	P		N	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/CD, M/CD Applications: Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 17 of 45

20

Device Name: PROSOUND F75 Transducer: UST-9115-5

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	P	P	P		N	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		N	Note 1
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE

Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/CD, M/CD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 18 of 45

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Device Name: PROSOUND F75 Transducer: UST-9118

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	Note 1
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note 1
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		P	Note 1
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
		Cardiac - Pediatric, TEE

Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD, B/CD/ PWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 19 of 45

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Device Name: PROSOUND F75 Transducer: UST-9120

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*	P	P	P		N	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic	P	P	P		N	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD Applications: Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 20 of 45

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Device Name: PROSOUND F75 Transducer: UST-9130

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		P	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/CD, M/CD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 21 of 45

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Device Name: PROSOUND F75 UST-9132 I & T Transducer:

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*	P	P	P		N	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Applications: Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 22 of 45

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Device Name: PROSOUND F75 Transducer: UST-9133

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging	Abdominal
& Other	Intra-operative (Specify)*	P	P	P		P	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic	P	P	P		P	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/PWD, M/CD,B/CD, B/CD/ PWD Applications: Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)__

Page 23 of 45

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Device Name: PROSOUND F75 Transducer:

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		N	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: M/CD, B/CD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _

Page 24 of 45

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Device Name: PROSOUND F75

Transducer: UST-9146 I & T

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*	P	P	P		N	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/CD, M/CD

Applications: Intra-operative - (liver, pancreas, gall bladder...)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 25 of 45

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Device Name: PROSOUND F75 Transducer: UST-9147

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	P	P	P		P	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 26 of 45

29

Device Name: PROSOUND F75 Transducer: UST-52105

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1, 2
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: M/CD, B/PWD, B/CD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Device Name: PROSOUND F75 Transducer: UST-52110S

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal	P	P	P	N	N	Note 1, 2
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE	N	N	N	N	N	Note 1, 2

Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: M/CD, B/CD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Device Name: PROSOUND F75 Transducer:

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal	P	P	P	P	P	Note 1, 2
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE	N	N	N	N	N	Note 1, 2
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Device Name: PROSOUND F75 Transducer:

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)	P	P	P		N	Note 1
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: M/CD, B/CD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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510(k)_

Page 30 of 45

33

Device Name: PROSOUND F75 Transducer:

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

Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging	Abdominal
& Other	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE	P	P	P	P	N	Note 1, 2
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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510(k)_

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34

Device Name: PROSOUND F75 Transducer:

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE	P	P	P	P	P	Note 1, 2
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

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Device Name: PROSOUND F75 Transducer: UST-52124

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic	P	P	P	P	P	Note 1, 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal	P	P	P	P	P	Note 1, 2
	Cardiac - Pediatric	P	P	P	P	P	Note 1, 2
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Device Name: PROSOUND F75 Transducer: GF-UE160 AL5

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*	P	P	P		P	Note 1
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)	P	P	P		P	Note 1
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify)
	Others (Specify) *	P	P	P		P	Note 1
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/PWD, B/CD

*: Specification for "Others" Gastrointestinal Tract and Surrounding Organs

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Page 34 of 45

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Device Name: PROSOUND F75 Transducer: GF-UCT180

| Clinical Application | (Specify) |
|---------------------------|----------------- | General
(Track I only) | Specific
(Tracks I & III) | B Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | Fetal | Fetal Imaging
& Other | Abdominal | P | | Intra-operative (Specify)* | | Intra-operative (Neuro.) | | Laparoscopic | | Pediatric | | Small Organ (Specify) | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | TEE (non-cardiac) | | Trans-esoph. (non-Card.) | | Musculo-skel. (Convent.) | | Musculo-skel. (Superfic.) | | Other: (Specify) | | Others (Specify) * | | Cardiac Adult | Cardiac | Cardiac Adult, TEE | | Cardiac - Neonatal | | Cardiac - Pediatric | | Cardiac - Pediatric, TEE | Peripheral
Vessel | Peripheral Vascular | | | Other (spec.) | Mode of Operation | | | | | | Other
-------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| M | PWD | CWD | Color
| | | | | | | |
| | | | | | | |
| P | P | | P | Note 1 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| P | P | P | P | P | Note 1 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| P | P | P | P | P | Note 1 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | |
| | | | | | | |

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD

*: Specification for "Others" Gastrointestinal Tract and Surrounding Organs

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

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Device Name: PROSOUND F75 Transducer: BF-UC180F

| Clinical Application | | Mode of Operation | | | | | | Other
(Specify) |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | P | P | P | | P | Note 1 | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) | | | | | | | |
| | Others (Specify) * | P | P | P | | P | Note 1 | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral
Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/PWD, M/CD, B/CD

*: Specification for "Others" Airways, Tracheobronchial tree

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Device Name: PROSOUND F75 Transducer: TGF-UC180J

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)	P	P	P		P	Note 1
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify)
	Others (Specify) *	P	P	P		P	Note 1
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K123828)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD

*: Specification for "Others" Gastrointestinal Tract and Surrounding Organs

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

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Page 37 of 45

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Device Name: PROSOUND F75 Transducer: UST-52126

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

Clinical Application	Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging	Abdominal
& Other	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE	N	N	N	N	N	Note 1, 2
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N = new indication.

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD Note 2: B/CWD, B/CD/CWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Page 38 of 45

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Device Name: PROSOUND F75 Transducer: UST-5296

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal	P	P	P	N	P	Note 1, 2
	Cardiac - Pediatric	N	N	N	N	N	Note 1, 2
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K122537)

Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use Only (Per 21 CFR 801.109)

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Page 39 of 45

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Device Name: PROSOUND F75 Transducer: UST-5418

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic	N	N	N		N	Note 1
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication.

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD,, B/CD/ PWD Applications: Intra-operative - (liver, pancreas, gall bladder ... )

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

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Page 40 of 45

43

Device Name: PROSOUND F75 Transducer: GF-UC140P-AL5

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)	P	P	P		P	Note 1
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *	P	P	P		P	Note 1
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE

Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K130058 - Olympus)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

*: Gastrointestinal Tract and Surrounding Organs

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44

Device Name: PROSOUND F75 Transducer: GF-UCT140-AL5

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)	P	P	P		P	Note 1
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *	P	P	P		P	Note 1
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA (K130058 - Olympus)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

*: Gastrointestinal Tract and Surrounding Organs

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Device Name: PROSOUND F75 Transducer: ASU-1014

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N		N	Note 1
	Abdominal	N	N	N		N	Note 1
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological	N	N	N		N	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication.

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD

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Device Name: PROSOUND F75 Transducer: UST-52128

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

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)*
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE	N	N	N	N	N	Note 1, 2
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication.

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

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Device Name: PROSOUND F75 Transducer: UST-52127

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify)
	Other: Gynecological
Cardiac	Cardiac Adult	N	N	N	N	N	Note 1, 2
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

N = new indication

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD,, B/CD/ PWD Note 2: B/CWD, B/CD/CWD

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48

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92, Subsection a

Submitter's Information

Hitachi Aloka Medical, Ltd. 10 Fairfield Boulevard Wallingford, CT 06492-5903

Contact: Angela Van Arsdale RA/QA Manager

Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Date Prepared: February 24, 2014

Device / Common / Classification Name / Classification / Product Code:

Device Proprietary Name - Prosound F75 Diagnostic Ultrasound System Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II Product Code: 90-IYN 892.1550 Ultrasonic Pulsed Imaging System 90-IYO 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer

1. Legally Marketed Predicate Device(s):
  Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]
1. Device Description:
  An ultrasound diagnostic system with the following features:
O Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected echoes O
A video monitor with optional image recorder to display the computed image or derived Doppler data O
1. Indication for Use:

The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac - Pediatric, TEE; Peripheral Vascular; and Gynecological applications.

The device is not indicated for Ophthalmic applications.

49

6. Comparison to predicate device:

The Hitachi Aloka Medical, Ltd. Hitachi Prosound F75 Diagnostic Ultrasound device is technically comparable and substantially equivalent to the currently marketed Hitachi Prosound Scanner [K123828]. The subject and predicate systems are track 3 systems that incorporate the same fundamental and scientific technologies.

	Subject	Predicate
	Hitachi Aloka Medical, Ltd.
Hitachi Prosound F75
Diagnostic Ultrasound
Scanner	Hitachi Aloka Medical, Ltd.
Prosound F75 Diagnostic
Ultrasound Scanner
[K123828]
Function
DICOM	YES	YES
DICOM SR	YES	YES
Real-time Tissue Elastography (feature updated)	YES	YES
Real-time 3D (feature updated)	YES	YES
STIC	YES	YES
3D STIC (STIC image enhancement)	YES	N/A
Automated IMT Measurement	YES	YES
Automated NT Measurement	YES	YES
eTRACKING	YES	YES
FMD	YES	YES
Wave Intensity	YES	YES
EFV	YES	YES
Stress Echo	YES	YES
AIP	YES	YES
DSD (Dynamic Slow-motion Display) [Predicate K122537]	YES	N/A
CHE	YES	N/A
Real-Time Doppler Auto Trace	YES	YES
Spatial Compound	YES	YES
FAM	YES	YES
Measurement Function	YES	YES
Dual Doppler	YES	N/A
Trapezoid	YES	YES
TDI	YES	YES
Display modes	B, 2B, 4B, M,
PW,CW,B/M,B/PW,B/CW, B(F),
2B(F), 4B(F), M(F),
B(T),2B(T),4B(T),M(T),
B(T)/M(T),B(T)/PW(T),B(T)/C
W, B/M/PW, B(F)/M(F)/PW,
M/PW,M(F)/PW,M(T)/PW	B, 2B, 4B, M,
PW,CW,B/M,B/PW,B/CW, B(F),
2B(F), 4B(F), M(F),
B(T),2B(T),4B(T),M(T),
B(T)/M(T),B(T)/PW(T),B(T)/C
W, B/M/PW, B(F)/M(F)/PW,
M/PW,M(F)/PW,M(T)/PW
PW Reference frequency	1.5,1.88, 2.14, 2.50, 3.00, 3.33,
3.75, 4.28, 5.00, 6.00, 7.50,
8.00MHz	1.88, 2.14, 2.50, 3.00, 3.33, 3.75,
4.28, 5.00, 6.00, 7.50, 8.00MHz

50

21 CFR Part 807.92, Section b

1. Non-clinical Testing

No new hazards were identified with the addition of the added indications and software features. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical safety, and have been found to conform to applicable medical device safety standards.

2. Clinical testing:

None required

3. Conclusions:

The Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device;

트 The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
. The subject and predicate device(s) have the same gray scale and Doppler capabilities.
. The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
트 The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
트 The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
트 The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
트 The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.
. The additional functions consist of currently cleared functions that have been enhanced or blended together providing enhanced image quality.

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Transducer Model Number

Indications for Use

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Device Name: PROSOUND F75 Transducer: UST-52110S

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Device Name: PROSOUND F75 Transducer:

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Device Name: PROSOUND F75 Transducer:

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Device Name: PROSOUND F75 Transducer:

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Device Name: PROSOUND F75 Transducer:

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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92, Subsection a

6. Comparison to predicate device:

21 CFR Part 807.92, Section b

1. Non-clinical Testing

2. Clinical testing:

None required

3. Conclusions:

END OF SUMMARY