The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; 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.

Device Description

The Prosound F75, formerly named Aloka Prosound F75, Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. Crucially, it explicitly states:

"No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).

... 2. Clinical Tests: None Required."

This indicates that no new primary clinical study was conducted for this specific 510(k) submission (K123828) to establish effectiveness against acceptance criteria for the expanded indications. Instead, the submission relies on the established safety and effectiveness of the previously cleared device (K110207) and predicate devices, leveraging existing knowledge and accepted medical practice for ultrasound systems.

Therefore, many of the requested details about a study and acceptance criteria (such as reported performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document as no new clinical studies were performed for this specific submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The acceptance criteria are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Aloka Prosound F75 (K110207) and other identified ultrasound systems (K033311, K032875). The key points for substantial equivalence, which serve as the "acceptance criteria" here, are:

Indicated for diagnostic ultrasound imaging and fluid flow analysis.
Same gray scale and Doppler capabilities.
Uses essentially the same technologies for imaging, Doppler functions, and signal processing.
Acoustic output levels below Track 3 FDA limits.
Manufactured under equivalent quality and manufacturing systems.
Manufactured of materials with equivalent biosafety.
Designed and manufactured to the same electrical and physical safety standards.

Reported Device Performance:
The document does not provide specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the expanded indications. Instead, it states that the clinical safety and effectiveness are "well accepted for use with ultrasound systems" and have been "identified in the previous Aloka Prosound F75 submission (K110207)". This means the performance is considered equivalent to the predicate devices, which are presumed to have established acceptable performance.

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

Sample Size: Not applicable. No new test set data from a clinical study was presented for this 510(k) submission.
Data Provenance: Not applicable for new clinical data. The submission relies on existing data from previous 510(k) submissions (K110207, K033311, K032875) which would have covered the safety and effectiveness of the base technology. The origin of that data is not specified in this summary.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No new test set was conducted for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this submission. The submission explicitly states "Clinical Tests: None Required."

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

Not applicable. The device is a diagnostic ultrasound system (hardware and software), not an algorithm-only device. No standalone performance study (in the sense of an AI algorithm) was conducted or needed for this hardware system and its expanded indications.

7. The Type of Ground Truth Used

Not applicable for this specific submission to demonstrate effectiveness for the expanded indications. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices. Any ground truth used for the original predicate device (K110207) or other predicate devices for their respective clinical applications would have been established at that time (e.g., clinical diagnosis, surgical findings, pathology, or other accepted diagnostic methods for ultrasound). This document does not elaborate on that.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "effectiveness" is based on the established performance of the underlying ultrasound technology already cleared with predicate devices.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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

Hitachi Aloka Medical, Ltd.

510(k) Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92

JAN 1 8 2013

Section a):

1. Submitter's contact name, address, telephone/fax number

: : : .

Angela Van Arsdale RA/OA Manager Hitachi Aloka Medical, Ltd., 10 Fairfield Boulevard Wallingford, CT 06492 Tel: (203)269-5088 Ext. 346 Fax: 203-269-6075

Date Prepared: 12/10/2012

2. Device Name:	Prosound F75 Diagnostic Ultrasound System
	90 IYN - Ultrasonic Pulsed Doppler Imaging System	21 CFR 892.1550
	90 ITX - Transducer Ultrasonic, Diagnostic	21 CFR 892.1570
	90 IYO - Ultrasonic Pulsed Echo Imaging System	21 CFR 892.1560

3. Substantially Equivalent Devices:

Aloka Prosound F75 Diagnostic Ultrasound System, (K110207), for system & probes. Aloka SSD-5000 V 5.0 Ultrasound System, (K033311), for expanded indications. Aloka SSD-5500 V6.0 Diagnostic Ultrasound System, (K032875), for expanded indications.

4. Device Description:

5. Indications for Use:

6. Comparison w/ Predicate Device:

The Prosound F75 with expanded indications is technically comparable and substantially equivalent to the current Aloka Prosound F75 (K110207) and to the above mentioned predicates. They are Track 3 systems that employ the same fundamental and scientific technology.

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

510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807,92

Section b):

1. Non-clinical Tests:
  No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).

The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards.

2. Clinical Tests: None Required.

ਤੇ Conclusion:

The Hitachi-Aloka Medical, Ltd.'s Prosound F75 with expanded indications is substantially equivalent in safety and effectiveness to the predicates identified above;

. The predicate device(s) and the Prosound F75 with expanded indications are indicated for diagnostic ultrasound imaging and fluid flow analysis,
The predicate device(s) and the Prosound F75 with expanded indications have the same . gray scale and Doppler capabilities.
. The predicate device(s) and the Prosound F75 with expanded indications use essentially the same technologies for imaging, Doppler functions and signal processing,
The predicate device(s) and the Prosound F75 with expanded indications have acoustic . output levels below the Track 3 FDA limits,
. The predicate device(s) and the Prosound F75 with expanded indications are manufactured under equivalent quality and manufacturing systems.
. The predicate device(s) and the Prosound F75 with expanded indications are manufactured of materials equivalent bio safety. The materials have been evaluated and found to be safe for this application.
. The predicate device(s) and the Prosound F75 with expanded indications are designed and manufactured to the same electrical and physical safety standards.

Note: The Hitachi-Aloka Medical, Ltd. Ultra-Sound System naming convention for this device can be identified as Aloka Prosound F75 or Prosound F75; both trade names reference the same device. The trade name, Aloka Prosound F75, listed within K110207 was modified to Prosound F75 prior to this premarket 510(K) submission and may be identified as "Prosound F75, formerly named Aloka Prosound F75" within the text of this submission. All the device instruction and operator manuals, advertisement and promotional materials, and labeling will identify the device as Prosound F75. The naming convention change is simply a marketing decision and not indicative of a separate device or any design modifications other than the modifications described with the body of this submission.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 18, 2013

Hitachi Aloka Medical, Ltd. c/o Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492

Re: K123828

Trade/Device Name: Prosound F75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYO Dated: December 10, 2012 Received: December 12, 2012

Dear Ms. Arsdale:

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.

This determination of substantial equivalence applies to the Prosound F75 and the following transducers intended for use with the Prosound F75 Ultrasonic pulsed Doppler Imaging System, as described in your premarket notification:

Transducer Model Number
UST-567	UST-5293-5	UST-9130	UST-52114P
UST-675P	UST-5411	UST-9132 I & T	UST-52119S
UST-677P	UST-5415	UST-9133	UST-52121S
UST-678	UST-5417	UST-9135P	UST-52124
ASU-1010	UST-5419	UST-9146 I & T	GF-UE160 AL
ASU-1012	UST-5713T	UST-9147	GF-UCT180
ASU-1013	UST-9115-5	UST-52105	BF-UC180F
UST-2265-2	UST-9118	UST-52110S	TGF-UC180
UST-2266-5	UST-9120	UST-52120S

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

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance, Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S for

Janine Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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

Hitachi Aloka Medical, Ltd.

Indications for Use

510(K) Number (if known):

Device Name:

Prosound F75

Indications For Use:

The device is intended for use by a qualified physician for ultrasound Fetal; evaluation of Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; 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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation Sean M. Boyd (Division Sign Off Division of Radiological He f In Vitro Diagnostics and Pit

Page 1 of 1

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

System: Prosound F75

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)*	P	P	P		P	Note 1
	Intra-operative (Neurosurgery)	N	N	N		N	Note 1
	Laparoscopic
	Pediatric	N	N	N		N
	Small Organ (Specify)*	P	P	P	N	P	Note 1,2
	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)	N	N	N		N	Note 1
	Musculo-skeletal (Convent.)	P	P	P		P	Note 1
	Musculo-skeletal (Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac, Adult	P	P	P	P	P	Note 1, 2
	Cardiac Adult, TEE	N	N	N	N	N	Note 1, 2
	Cardiac- Neonatal	N	N	N	N	N	Note 1, 2
	Cardiac- Pediatric	N	N	N	N	N	Note 1, 2
	Cardiac Pediatric, TEE	N	N	N	N	N	Note 1, 2
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular	P	P	P	N	P	Note 1,2
	Other: Gynecological	P	P	P		P	Note 1

Intended Use: Diggnostic ultrasound im

N = new indication; P= previously cleared by FDA-(K110207); E=added under Appendix E

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

Note 3: Specification for "Other" Airways, Tracheobronchial tree, Gastrointestinal Tract and Surrounding Organs * Applications: Small Parts - (breast, testes, & thyroid...), Intra-operative - (liver, pancreas, gall bladder ...)

Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd
(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiology

510(k) K123828

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

System: Prosound F75 Transducer: UST-567

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

	Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)*	P	P	P		P	See note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)	P	P	P		P	See note 1
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular	P	P	P		P	See note 1
	Other: Gynecological

P= previously cleared by FDA-(K110207)

Combination of each operating mode includes: Note 1: BM, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD * Applications: Small Parts - (breast, testes, & thyroid...), Intra-operative - (liver, pancreas, gall bladder ... ) Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Health

510(k) K123828

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

System: Prosound F75 Transducer: UST-675P

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

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	See note 1
	Trans-vaginal	P	P	P		P	See note 1
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular
Vessel	Other: Gynecological

P= previously cleared by FDA- (K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

Sean M. Boyd -

(Division Sign Off)

Division of Radiological Health

510(k) K123828

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	E	E	E		E
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Pe

Sean M. Boyd -S
(Division Sign Off)

Division of Radiological Health

s10(K123828

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

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	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	E	E	E		E
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

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

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -S

(Division Sign Off)

റ്റിഗ് of Radiological Health

วาน(k) K123828

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

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological	P	P	P		P	Note 1

P= previously cleared by FDA- (K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -

(Division Sign Off)

Division of Radiological Health

510(k) K123828

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

System: 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	Specific	B	M	PWD	CWD	Color	Combined	Other
(Track 1 Only)	(Tracks 1 & 3)					Doppler	(Specify)	(Specify)
Ophthalmic	Ophthalmic
	Fetal	E	E	E
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	E	E	E
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular
Vessel	Other: Gynecological	E	E	E

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

51000 K123828

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

System: Prosound F75 Transducer: ASU-1013

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)	E	E	E
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

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

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ean M

(Division Sign Off)

Division of Radiological Health

Office of In vitro Ulagnostics and Rad

510(k) K123828

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound F75 Transducer: UST-2265-2

		Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	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
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult				P
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other :Gynecological

N = new indication; P= previously cleared by FDA- (K110207)

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

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

Prescription Use (Per 21 CFR 801.109)

ean IV

(Division Sign Off)

Division of Radiological Heatth

510(k) K123828

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

System: Prosound F75 Transducer: UST-2266-5

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
		company of collection of confidence of the driver of the driver of the driver of

Clinical Application			Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult				P
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular				P
Vessel	Other : Gynecological

P= previously cleared by FDA- (K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 C

sean M

(Division Sign Off)

Division of Radiological Health

510(k) K123828

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

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult	P	P	P	P	P	Note 1, 2
	Cardiac Adult, TEE	N	N	N	N	N	Note 1, 2
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other (Gynecological)

N = new indication; P = previously cleared by FDA -(K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Sign Off)

Division of Radiological Health

് it in vitro Ulagnostics and Radiological Health

510(k) K123828

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

System: 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	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)*	P	P	P		P	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)	P	P	P		P	Note 1
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular	P	P	P		P	Note 1
	Other :Gynecological

N = new indication; P= previously cleared by FDA- (K110207)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD * Applications: Small Parts: (breast, testes, & thyroid ... )

Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radlological Health

510(k) K123828

ട്ട

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

System: 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	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	Ophthalmic
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)*	P	P	P		P	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)	P	P	P		P	Note 1
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular	P	P	P		P	Note 1
	Other: Gynecological

P= previously cleared by FDA- (K110207)

P= previously cleared by PDA- (RT10207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/CWD Combinations: Small Parts -- (breast, testes, & thyroid...), Intra-operative - (liver, pancreas, gall bladder ... ) Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C eal

(Division Sign Off)

Division of Radiological Health

510(k) K123828

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

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)*	E	E	E
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral Vascular	E	E	E
	Other: Gynecological

E=added under Appendix E

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CDPWD Note 2: B/CWD, B/CD/CWD *Applications: Small Parts - (breast, testes, & thyroid ... ), Intra-operative - (liver, pancreas, gall bladder ... ) Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M Rovn (Division Sign Off)

Division of Radiological Health

510(k) K123828

{19}------------------------------------------------

System: Prosound F75 Transducer: UST-5419

		Mode of Operation
		B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	E	E	E
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral Vascular	E	E	E
	Other: Gynecological

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

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Sean M.

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123828

ട്ക

{20}------------------------------------------------

System: Prosound F75 Transducer: UST-5713T

General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
	Peripheral	Peripheral Vascular
	Vessel	Other: Gynecological

Intended Use: Diagnostic ultrasound imaging or flyid flow analysis of the human body fallows

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M.

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{21}------------------------------------------------

System: Prosound F75 Transducer: UST-9115-5

	Mode of Operation
General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	E	E	E
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral Vascular
	Other: Gynecological	E	E	E

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

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{22}------------------------------------------------

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	Color Doppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Note 1
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note 1
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Other: Gynecological	P	P	P		P	Note 1

P= previously cleared by FDA- (K110207)

P= previously cleared by FDA- (KT10207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801 109)

Sean M. Bc

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{23}------------------------------------------------

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic	E	E	E
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ean M. Bovo

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Ra

510(k) K123828

{24}------------------------------------------------

System: 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	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological	P	P	P		P	Note 1

N = new indication; P= previously cleared by FDA- (KI10207)

1 - Inchestion of each operating mode includes: Note 1: BM, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801_109)

Sean M. Boy

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{25}------------------------------------------------

System: Prosound F75 Transducer: UST-9132 I & T

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

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M. Boyo

(Division Sign Off

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123828

{26}------------------------------------------------

System: Prosound F75 Transducer: UST-9133

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)*	P	P	P		P	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic	P	P	P		P	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

P= Previously cleared by FDA- (K110207)

Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD * Applications: Intra-operative - (liver, pancreas, gall bladder ... )

Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

Division of Radiological Health

510(k) /1/23828

{27}------------------------------------------------

System: Prosound F75 Transducer: UST-9135P

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	E	E	E
	Intra-operative (Specify).
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult
		Cardiac Adult, TEE
		Cardiac- Neonatal
		Cardiac Pediatric, TEE
		Intravascular (Cardiac)
		Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

E=added under Appendix E

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K193828

ନ୍ୟ

{28}------------------------------------------------

System: Prosound F75 Transducer: UST-9146 I&T

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

Clinical Application			Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	P	P	P	P		Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

P= previously cleared by FDA- (K110207)

1 = previously cliarco of PDS- (1110207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD . Note 2: B/CWD, B/CD/CWD Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M. Boyd

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{29}------------------------------------------------

System: Prosound F75 Transducer: UST-9147

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac) .
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological	P	P	P		P	Note 1

P= previously cleared by FDA- (K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M

(Division Sign Off)

Division' of Radiological Health

Office of In Vitro Diagnostics and Radiological Hs

510(k) K123828

୧୫

{30}------------------------------------------------

System: Prosound F75 Transducer: UST-52105

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1 & 2
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

P= previously cleared by FDA- (K110207)

1 - previously cleared of PDIT (terrors) /
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

510(k) /1123828

{31}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 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 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal	N	N	N
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

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 Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Sean M. Boyo

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{32}------------------------------------------------

System: Prosound F75 Transducer: UST-52120S

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

	Mode of Operation
General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE					E	Note 1 & 2
Cardiac	Cardiac- Neonatal	E	E	E	E	E	Note 1 & 2
	Cardiac Pediatric	E	E	E	E	E	Note 1 & 2
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

N = new indication

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 Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Sean McBoyd -S

Division of Radiological Health

the or In Vitm Diagnostics and Radiological Health

K123828

{33}------------------------------------------------

System: Prosound F75 Transducer: UST-52114P

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative(Neurosurgery)	N	N	N
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral Vascular
	Other: Gynecological

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

N = new indication

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (P

Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

Office of in Vitro Diagnostics and Ria

510(k) K123828

{34}------------------------------------------------

System: Prosound F75 Transducer: UST-52119S

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE	N	N	N	N		Note 1, 2, 3
	Intravascular (Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular
Vessel	Other: Gynecological

N = new indication

N = new markation
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Note 3: Cardiac, Pediatric cleared by FDA – (K110287) Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{35}------------------------------------------------

System: Prosound F75 Transducer: UST-52121S

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

	Mode of Operation
General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative(Neurosurgery))
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skelctal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE	N	N	N	N	N	Note 1,2, 3
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVassal	Peripheral Vascular
	Other: Gynecological

N = new indication

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 Note 3: Cardiac, Pediatric cleared by FDA - (K110287)

Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd -S

(Division Sign Off)

Division of Radiological Health

510(k) K123828

{36}------------------------------------------------

System: Prosound F75 Transducer: UST-52124

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmi	Ophthalmic
c
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic	P	P	P	P	P	Note 1, 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal	P	P	P	P	P	Note 1, 2
	Cardiac-Pediatric	N	N	N	N	N	Note 1, 2
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular
Vessel	Other: Gynecological

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

N = new indication; P= previously cleared by FDA- (K110207)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

escription Use (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Sign Off)

Division of Radiological Hea

Office of In Vitro Diagnostics and R

510(k) K123828

{37}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound F75 Transducer: GF-UE160 AL5

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal			P		P	Note 1
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)	P	P	P		P	Note 1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)	P	P	P		P	Note 1
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Others (Specify) Note 2	P	P	P		P	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

N = new indication; P= previously cleared by FDA via K051541; E=added under Appendix E Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Specification for "Other" Airways, Tracheobronchial tree, Gastrointestinal Tract and Surrounding Other:

Note 2:

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

Prescription Use (Per 21 CFR 801

ean

(Division Sign Off)

Division of Radiological Heatth

510(k) K123828

{38}------------------------------------------------

System: Olympus Endoscope for use with Aloka Ultrasound System Transducer: GF-UCT180

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
Fetal Imaging& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)	P	P	P		P	Note 1
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Others (Specify) Note 2	P	P	P		P	Note 1
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
PeripheralVessel	Other (Specify)
	Peripheral Vascular
	Other: Gynecological

N = new indication; P= preyiously cleared by FDA K093395; E=added under Appendix E Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: Specification for "Other" Gastrointestinal Tract and Surrounding Organs Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109) Sean M

ITTivision Sign Off)

Danston: of Radiological Health

. Mice of In Vitro Liagnostics and Radiological H

510(k) K123828

{39}------------------------------------------------

System: Olympus Endoscope for use with Aloka Ultrasound System Transducer: BF-UC180F

Clinical Application Mode of Operation General Specific B PWD M CWD Color Combined Other (Track 1 (Tracks 1 & 3) (Specify) Doppler (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ (Specify) Fetal Imaging Neonatal Cephalic & Other Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral TEE (non-Cardiac) P P P P Note l Musculo-skeletal (Convent.) Musculo-skeletal (Superficial) Intravascular Intra-luminal Others (Specify) Note 2 P P P P Note l Cardiac Adult Cardiac Adult, TEE Cardiac Cardiac- Neonatal Cardiac Pediatric, TEE Intravascular (Cardiac) Other (Specify) Peripheral Peripheral Vascular Vessel Other: Gynecological

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

N = new indication; P= previously cleared by FDA K070983; E=added under Appendix E Combination of each operating mode includes: Note 1: B/M, B/PWD, B/CD/PWD;

Note 2: Specification for "Other" Airways, Tracheobronchial tree Other:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

Olvision of Radiological Health

510(k) K/23828

{40}------------------------------------------------

System: Olympus Endoscope for use with Aloka Ultrasound System Transducer: TGF-UC180J

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	TEE (non-Cardiac)	P	P	P		. P	Note 1
	Musculo-skeletal (Convent.)
	Musculo-skeletal(Superficial)
	Intravascular
	Intra-luminal
	Other (Specify) Note 2	P	P	P		P	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac- Neonatal
	Cardiac Pediatric, TEE
	Intravascular (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral Vascular
	Other: Gynecological

N = new indication; P= previously cleared by FDA K093395; E=added under Appendix E Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: Specification for "Other" Gastrointestinal Tract and Surrounding Organs Other:

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Sean M. Boyd -S

il nuision Sign Off)

ാസ്യങ്ങൾ of Radiological Health -

510(k) K123828

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.