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

K122537 · Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · IYN · Apr 12, 2013 · Radiology

Device Facts

• Record ID: K122537
• Device Name: PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
• Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
• Product Code: IYN · Radiology
• Decision Date: Apr 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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 Story

Prosound Alpha 7 Ver. 6.0 is a mobile diagnostic ultrasound system; provides image acquisition, processing, and display. Operates via user interface with keyboard and specialized controls. Inputs are ultrasonic signals from various transducers; system transforms these into B-mode, M-mode, PWD, CWD, and Color Doppler images. Used in clinical settings by physicians for diagnostic imaging and fluid flow analysis. Output displayed on console for clinical interpretation; aids in diagnosis and patient management. Benefits include non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety testing.

Technological Characteristics

Mobile console-based diagnostic ultrasound system. Supports various transducers (e.g., UST-533, UST-534, etc.). Imaging modes: B, M, PWD, CWD, Color Doppler. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485. Safety compliance verified via independent evaluation of acoustic output, biocompatibility, and electrical/mechanical safety standards.

Indications for Use

Indicated for qualified physicians performing ultrasound evaluation of fetal, abdominal, intra-operative (including neuro/burr hole), laparoscopic, pediatric, neonatal cephalic, trans-rectal/vaginal, musculoskeletal, gynecological, cardiac (adult, neonatal, pediatric), TEE, and peripheral vascular applications. Not indicated for ophthalmic use.

Regulatory Classification

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.

Predicate Devices

• Aloka SSD- Alpha 7 Diagnostic Ultrasound System (K072285)
• Aloka SSD-5500 (K032875)
• Aloka Prosound F75 (K110207)
• Aloka SSD-5000 (K012080)

Submission Summary (Full Text)

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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.,<br>Tel: [phone] Ext. 346, Fax: [phone] |
| Date Prepared: | 7/10/12 |
| 2. Device Name: | Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX<br>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.<br>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 |

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| 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

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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)

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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

Page 1 of 50

Page 001 of 50

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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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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)

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# 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<br>(Track I<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& 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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& 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)

Page 004 of 50

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21.

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# 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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& 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<br>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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### 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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& 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<br>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)

Page 006 of 50

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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<br>(Track 1<br>Only) | Clinical Application<br>Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
|------------------------------|----------------------------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& 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<br>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)

> > Page 007 of 50

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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<br>(Track I<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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)

Page 008 of 50

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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<br>(Specify) | Other<br>(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro), Burr Hole | | | | | | | |
| | Inter-operative, Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& 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<br>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<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& 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<br>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<br>(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(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, Laparos…