PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

• K Number: K122537
• Device Name: PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
• Manufacturer: HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
• Date Cleared: 2013-04-12 ( 235 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular. The device is not indicated for Ophthalmic applications.

Device Description

The Prosound Alpha 7 Ver. 6.0 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.

Predicate Devices

Aloka SSD- Alpha 7 Diagnostic Ultrasound System K072285

Reference Devices

K032875, K110207, K012080

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on standard ultrasound system components and capabilities.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "ultrasound evaluation" and provides "acquisition, processing and display capability," which are functions consistent with diagnosis rather than therapy.

Diagnostic

Yes
The "Device Description" explicitly states, "The Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System is a full feature imaging and analysis system," and the name includes "Diagnostic Ultrasound System." Additionally, the "Intended Use / Indications for Use" section lists various anatomical sites for "ultrasound evaluation," which is a diagnostic activity.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console" and mentions "acquisition, processing and display capability," indicating it includes hardware components beyond just software. The performance studies also mention testing of "transducers" and "electrical and mechanical safety," further confirming the presence of hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
• Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures within the body.
• Intended Use: The intended use describes the device being used for ultrasound evaluation of various anatomical sites on patients.
• No Mention of Samples: There is no mention of the device analyzing samples taken from the body.

Therefore, the Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System is an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular.
The device is not indicated for Ophthalmic applications.

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

IYN, IYO, and ITX

Device Description

The Prosound Alpha 7 Ver. 6.0 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), Peripheral Vascular.

Indicated Patient Age Range

Adult, Neonatal, Pediatric, Fetal.

Intended User / Care Setting

qualified physician

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 Tests: 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.
Clinical Tests: None Required.

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

Not Found

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

Aloka SSD- Alpha 7 Diagnostic Ultrasound System K072285

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

K032875, K110207, K012080

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Hitachi Aloka Medical, Ltd.

Prosound Alpha 7 Ver. 6.0

510(K) K22537

APR 1 2 2013

510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

.

Section a):
1. Submitter:	Hitachi Aloka Medical Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492
Contact Person:	Angela Van Arsdale, RA/QA Mngr.,
Tel: [phone] Ext. 346, Fax: [phone]
Date Prepared:	7/10/12
2. Device Name:	Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX
Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO
3. Substantially Equivalent devices:	Aloka SSD- Alpha 7 Diagnostic Ultrasound System K072285 for probes and system. Aloka SSD-5500 (K032875), Aloka Prosound F75 (K110207), and Aloka SSD-5000 (K012080) for expanded indications.
4. Device Description:	The Prosound Alpha 7 Ver. 6.0 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.
5. Indications for Use:	The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular.
The device is not indicated for Ophthalmic applications.
6.Comparison w/ Predicate Device:	The Prosound Alpha 7 Ver. 6.0 is technically comparable and substantially equivalent to the current Aloka SSD- Alpha 7 -(K072285). It has the same technological characteristics, key safety and effectiveness features, and has the same uses and basic operating modes as the predicate device.
Section b):
I. Non-clinical Tests:	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.
3. Conclusion:	Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Hitachi Aloka Medical, Ltd. that the Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System and its transducers are equivalent with respect to safety and effectiveness to its predicate and other currently cleared Hitachi Aloka Medical systems.

//

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

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

April 12, 2013

Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical AMERICA) % Mr. Michael S. Ogunleye 510(k) Program Manager/Medical Lead Auditor TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K122537

Trade/Device Name: Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 4, 2013 Received: March 13, 2013

Dear Mr. Ogunleye:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

UST-533	UST-534
UST-536	UST-547
UST-567	UST-675
UST677P (L&T)	UST-678 (C&L)
UST-984-5	ASU-1010

2

ASU-1012	ASU-1013
UST-2265-2	UST-2266-5
UST-5045P-3.5	UST-5293-5
UST-5296	UST-5411
UST-5412	UST-5534T-7.5
UST-5536-7.5	UST-5543
UST-5548	UST-5550
UST-5712	UST-5713T
UST-9101-7.5	UST-9104-5
UST-9115-5	UST-9118
UST-9120	UST-9128
UST-9130	UST-9132 I/T
UST-9133	UST-9135P
UST-9136U	UST-9146 I/T
UST-52101	UST-52105
UST-52108	UST-52109
UST-52110S	UST-52114P
UST-52119S	UST-52120S
UST-52121S	UST-52124

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

3

Page 3 – Mr. Ogunleye

CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours,

Mi

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

4

510(k) Number (if known): K122537

Device Name:

Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System

Indications for Use:

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal. Abdominal. Intra-operative (Neuro). Laparoscopic. Pediatric. Neonatal Cephalic. Transrectal & vaginal. Musculoskeletal. Gynecological. Cardiac (Adult. Neonatal. Pediatric). TEE & Peripheral Vascular.

The device is not intended for ophthalmic applications.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(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)

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

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1.3.1

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0

intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow~

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	Note 2
	Abdominal	P	P	P		P	Note 1	Note 2
	Intra-operative (Specify)	P	P	P		P	Note 1
	Intra-operative (Neuro), Burr Hole	N	N	N		N	Note 1
	Inter-operative, Laparoscopic	N	N	N		N	Note 1
	Pediatric	N	N	N		N	Note 1
Fetal Imaging	Small Organ (Specify)	P	P	P		P	Note 1	Note 2
& Other	Neonatal Cephalic	P	P	P		P	Note 1	Note 2
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1
	Trans-vaginal	P	P	P		P	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	P	P	P		P	Note 1	Note 2
	Musculo-skeletal (Superfical)
	Other : Gynecological	P	P	P		P	Note 1	Note 2
	Cardiac Adult	P	P	P		P	Note 1	Note 2
	Cardiac Adult, TEE	N	N	N		N	Note 1	Note 2
Cardiac	Cardiac Pediatric, TEE	N	N	N		N	Note 1	Note 2
	Cardiac Neonatal, TEE	N	N	N		N	Note 1	Note 2
	Cardiac, Pediatric	N	N	N		N	Note 1	Note 2
	Cardiac, Neonatal	N	N	N		N	Note 1	Note 2
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular	P	P	P		P	Note 1	Note 2
Vessel	Other (Specify)

= new indication for system; P= Previously cleared K072285, E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

Applications:- Intra-operative- (Iiver, III GB, EroBH WD
Applications:- Intra-operative- (liver, pancreas, gall bladder, ....), Small Organ- (breast, testes, thyroid....).

(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)

6

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-533

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

Clinical Application		Mode of Operation
General
(Track I
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
Vessel	Other (Specify)

ation for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

7

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-534

..

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
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
Vessel	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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8

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-536

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
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

(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)

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9

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-547

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
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic	E	E	E		E	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

new indication for system; E = added to Alpha 7 under Appendix E,

Combined: Note I : B/M, B/PWD, M/CD, B/CD/PWD

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

(BLEASE 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)

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System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-567

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

| General
(Track 1
Only) | Clinical Application
Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other
(Specify) |
|------------------------------|----------------------------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | E | E | E | | E | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | E | E | E | | E | Note 1 | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | E | E | E | | E | Note 1 | |
| | Other (Specify) | | | | | | | |

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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・

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-675

	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 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note I
	Trans-vaginal	P	P	P		P	Note I
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
Vessel	Other (Specify)

N indication for system; P= Previously cleared K072285

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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12

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST677P (L&T)

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

| Clinical Application | | Mode of Operation | | | | | Combined
(Specify) | Other
(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | E | E | E | | E | Note 1 | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 009 of 50

13

.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-678 (C&L)

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	E	E	E		E	Note 1
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

.27

14

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-984-5

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	E	E	E	E	E	Note 1
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	E	E	E		E	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

15

System: Prosound Alpha 7 Ver. 6.0 Transducer: ASU-1010

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

| Clinical Application | | Mode of Operation | | | | | | Other
(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | Note 1 | |
| | Abdominal | P | P | P | | P | Note 1 | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | P | P | P | | P | Note 1 | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication for system; P= Previously cleared K072285,

Combined: 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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Page 012 of 50

16

System: Prosound Alpha 7 Ver. 6.0 Transducer: ASU-1012

.

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

	Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	Note 1
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	E	E	E		E	Note 1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

Page 013 of 50

રી

17

System: Prosound Alpha 7 Ver. 6.0 Transducer: ASU-1013

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note I
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	E	E	E		E	Note I
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note I
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) . .

Page 014 of 50

18

System: Prosound Alpha 7 Ver. 6.0 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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult				E
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evatuation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 015 of 50

19

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-2266-5

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult					E
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular					E
	Other (Specify)

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

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: Note I: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 016 of 50

કુંડ

20

Prosound Alpha 7 Ver. 6.0

. İ

.......

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5045P-3.5

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
	Abdominal	E	E	E		E	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the

N = new indication for system; E = added to Alpha 7 under Appendix E,

Combined: Note I : 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

21

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0

Transducer: UST-5293-5

ATTORNEY: 601-522-3

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

	Clinical Application
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE	N	N	N		N	Note 1	Note 2
	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; P= Previously cleared-K032875

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 018 of 50

22

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5296

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

| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other
(Specify) |
|------------------------------|------------------------------------|------------|------------|-----|-----|------------------|-----------------------|--------------------|
| | | Ophthalmic | Ophthalmic | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | N | N | N. | | N | Note 1 | Note 2 |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication for system; P= Previously cleared K072285,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 019 of 50

23

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5411

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human bedy 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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	E	E	E		E	Note 1
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note I: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 020 of 50

60

24

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5412

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	P	P	P	P	P	Note 1	Note 2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	P	P	P	P	P	Note 1	Note 2
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	P	P	P	P	P	Note 1	Note 2
	Other (Specify)

cviously cleared K072285,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 021 of 50

25

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5534T-7.5

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

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

Prescription Use (Per 2 I CFR 801.109)

Page 022 of 50

62

26

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5536-7.5

.

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic	N	N	N		N	Note 1
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; P= Previously cleared-K 032875

Combined: Note I : B/M, B/PWD, M/CD, B/CD/PWD

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

(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)

Page 023 of 50

ﺎ

27

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5543

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note I
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	E	E	E		E	Note I
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note I
	Other (Specify)

= added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) .

Prescription Use (Per 21 CFR 801.109)

28

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5548

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 025 of 50

29

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-5550

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic	N	N	N		N	Note I
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system;

Combined: 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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Page 026 of 50

દર્ભ

બંત્ર

30

System: Prosound Alpha 7 Ver. 6.0 Transducer; UST-5712

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)	E	E	E		E	Note 1
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Applications:- Small Organ- (breast, testes, thyroid ... ).

M

(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)

Page 027 of 50

67

31

System: Prosound Alpha 7 Ver. 6.0 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 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

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

Prescription Use (Per 21 CFR 801.109)

Page 028 of 50

68

નર્ડ

32

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9101-7.5

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric	N	N	N		N	Note 1
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = acw indication for system; P= Previously cleared K072285, E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

(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)

Page 029 of 50

33

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9104-5

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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)	E	E	E		E	Note 1
& Other	Neonatal Cephalic	E	E	E		E	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
Vessel	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 030 of 50

34

··

,

Prosound Alpha 7 Ver. 6.0

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 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 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	E	E	E		E	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric, Abdominal
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other: Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system;

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 031 of 50

.

. .

35

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9118

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

| Clinical Application | | Mode of Operation | | | | | | Other
(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | Note I | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | Note I | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | P | P | P | | P | Note I | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

P= Previously cleared K072285,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Applications:- Intra-operative- (liver, pancreas, gall bladder, ... ), Small Organ- (breast, testes, thyroid... . .

(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)

· Page 032 of 50

4g

36

System; Prosound Alpha 7 Ver, 6.0 Transducer: UST-9120

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

| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other
(Specify) |
|------------------------------|------------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | P | P | | P | Note I | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note I | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | | | | | | | |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

P= Previously cleared K072285,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 033 of 50

73

37

·

Г

.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9128

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
Fetal Imaging
& Other	Abdominal	E	E	E		E	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric, Abdominal
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system;

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

CLEASE 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)

Page 034 of 50

38

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9130

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	Note 2
	Abdominal	P	P	P		P	Note 1	Note 2
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	P	P	P		P	Note 1	Note 2
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

Intended Use: Diagnostic ultr d imsging or fluid Aou onalusis

P= Previously cleared K072285

Combined: Note I : 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 Device Evaluation (ODE)

.

39

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9132 I/T

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

	Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note I
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)	E	E	E		E	Note I
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular	E	E	E		E	Note 1
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

(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)

Page 036 of 50

76

40

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging
& Other	Abdominal	E	E	E		E	Note I
	Intra-operative (Specify)	E	E	E		E	Note I
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

= added to Alpha 7 under Appendix E, ה

Combined: 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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

41

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9135P

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

	Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	Note 1
	Abdominal	E	E	E		E	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 038 of 50

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42

.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-9136U

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	E	E	E		E	Note 1
	Abdominal	E	E	E		E	Note 1
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging	Small Organ (Specify)	E	E	E		E	Note 1
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological	E	E	E		E	Note 1
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
Vessel	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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System: Prosound Alpha 7 Ver. 6.0 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 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)	E	E	E		E	Note 1
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 040 of 50

44

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52101

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 Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
Cardiac	Cardiac Adult	P	P	P		P	Note 1	Note 2
	Cardiac Adult, TEE
	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

P= Previously cleared K072285

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801,109)

Page 041 of 50

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45

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver, 6.0 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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult	E	E	E	E	E	Note 1	Note 2
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

E = added to Alpha 7 under Appendix E,

Combined: Note I: B/M, B/PWD, M/CD, B/CD/PWD Applications:- Intra-operative- (liver, pancreas, gall bladder, ....), Small Organ- (breast, thyroid... ).

(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)

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46

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52108

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric	N	N	N	N	N	Note 1	Note 2
	Cardiac, Neonatal	N	N	N	N	N	Note 1	Note 2
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

(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)

Page 043 of 50

હ્યું છે

47

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52109

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

		Mode of Operation
General
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic	N	N	N		N	Note 1
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

new indication for system; P= Previously cleared-K032875

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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System: Prosound Alpha 7 Ver. 6.0 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	Color
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE	N	N	N	N	N	Note 1	Note 2
	Cardiac Neonatal, TEE	N	N	N	N	N	Note 1	Note 2
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system;

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

49

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52114P

Intended Use: Diagnostic ultrasound imaging or Nuid 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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole	N	N	N		N	Note 1
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system

Combined: Note 1: B/M, B/PWD, M/CD, B/CD/PWD

(PLEASE DQ 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)

50

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52119S

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE	N	N	N	N	N	Note 1	Note 2
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system , P= Previously cleared-K110207

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 047 of 50

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52120S

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal	N	N	N		N	Note 1	Note 2
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; P= Previously cleared K032875, E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 048 of 50

52

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52121S

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
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro), Burr Hole
	Inter-operative, Laparoscopic
	Pediatric
Fetal Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Convent.)
	Musculo-skeletal (Superfical)
	Other : Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
Cardiac	Cardiac Pediatric, TEE
	Cardiac Neonatal, TEE
	Cardiac, Pediatric
	Cardiac, Neonatal	N	N	N		N	Note 1	Note 2
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vascular
	Other (Specify)

N = new indication for system; P= Previously cleared K110207, E = added to Alpha 7 under Appendix E,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 049 of 50

ים יו

53

System: Prosound Alpha 7 Ver. 6.0 Transducer: UST-52124

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

| General
(Track 1
Only) | Clinical Application
Specific
(Tracks 1 & 3) | B | M | PW
D | CWD | Mode of Operation | | |
|------------------------------|----------------------------------------------------|---|---|---------|-----|-------------------|-----------------------|--------------------|
| | | | | | | Color
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging
& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superfical) | | | | | | | |
| | Other : Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac Pediatric, TEE | | | | | | | |
| | Cardiac Neonatal, TEE | | | | | | | |
| | Cardiac, Pediatric | N | N | N | | N | Note 1 | Note 2 |
| | Cardiac, Neonatal | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

new indication for system; P= Previously cleared K110207,

Combined: 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$\sinh(x)$

510(k) # K122537

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

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