ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

K110207 · Aloka Co., Ltd. · IYN · Feb 17, 2011 · Radiology

Device Facts

• Record ID: K110207
• Device Name: ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Aloka Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 17, 2011
• 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 Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal, Trans-rectal, Musculo-skeletal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

Device Story

Prosound F75 is a mobile diagnostic ultrasound system for imaging and fluid flow analysis. It acquires, processes, and displays ultrasound data via a console with a keyboard and specialized controls. Operated by qualified physicians in clinical settings, it supports various modes including B, M, PWD, CWD, Color Doppler, and combined modes. The system processes acoustic signals from connected transducers to generate real-time images, aiding clinicians in diagnostic evaluations across multiple anatomical applications. It facilitates clinical decision-making by providing visual diagnostic information. Benefits include non-invasive assessment of internal structures and hemodynamics.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety. No clinical data was required for this submission.

Technological Characteristics

Mobile diagnostic ultrasound console. Supports A, B, M, PWD, CWD, Color Doppler, and combined modes. Compatible with various Aloka transducers. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. Electrical and mechanical safety verified per applicable standards.

Indications for Use

Indicated for ultrasound evaluation of small parts, abdominal, cardiac, peripheral vascular, fetal, intra-operative, trans-vaginal, trans-rectal, musculo-skeletal, and neonatal cephalic applications in patients requiring diagnostic ultrasound imaging or fluid flow analysis. Not indicated for ophthalmic applications.

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 Alpha 10 Diagnostic Ultrasound System (K043196)

Reference Devices

• UST-567 (K041916)
• UST-675P (K992663)
• ASU-1010 (K043196)
• UST-2265-2 (K012080)
• UST-2266-5 (K963616)
• UST-5293-5 (K003739)
• UST-5411 (K043196)
• UST-5415 (K043196)
• UST-9118 (K992663)
• UST-9130 (K043196)
• UST-9133 (K060059)
• UST-9146I (K963616)
• UST-9146T (K963616)
• UST-9147 (K043196)
• UST-52105 (K032875)
• UST-52119S (K003739)
• UST-52121S (K003739)
• UST-52124 (K032875)

Submission Summary (Full Text)

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#### Model Prosound F75

510(K)

1026 KI FEB 1 7 2011

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

| Section a): | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Submitter: | Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 |
| Contact Person: | Richard J. Cehovsky, RA/QA Mngr.,<br>Tel: [phone] Ext. 346, Fax: [phone] |
| Date Prepared: | 11/24/2010 |
| 2. Device Name: | Aloka Prosound F75 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. Marketed Device: | Aloka Alpha 10 Diagnostic Ultrasound System, K043196, (90-IYN, ITX, IYO)<br>( A device currently in commercial distribution) |
| 4. Device Description: | The Prosound F75 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. |
| 5. Indications for Use: | The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications. |
| 6. Comparison w/ Predicate Device: | The Aloka Prosound F75 is technically comparable and substantially equivalent to the current Aloka Alpha 10-(K043196). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device. |
| Section b): | |
| 1. 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 confirms with 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 Aloka Co., Ltd. that the Aloka Prosound F75 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems. |

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New Indications for Use: There are no new indications for use. 1.3.2

#### Previously Cleared Indications for Use: 1.3.3

The Prosound F75 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Small Parts, Intraoperative, Abdominal, Gynecological, Cardiac, Musculo-skeletal, Transvaginal, Neonatal: Cephalic, Fetal & Peripheral Vascular.

The Prosound F75 has the same indications for use as its predicate - Aloka Alpha 10- (K043196) and other market cleared systems and transducers manufactured by Aloka.

Promotional information for the Prosound F75 is provided in Appendix D of this submission.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

FEB 1 7 2011

Re: K110207

Trade/Device Name: Aloka Prosound F75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 14, 2011 Received: January 25, 2011

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 the Aloka Prosound F75, as described in your premarket notification: ··

#### Transducer Model Number

| UST-567 | UST-5411 | UST-9146T |
|------------|-----------|------------|
| UST-675P | UST-5415 | UST-9147 |
| ASU-1010 | UST-9118 | UST-52105 |
| UST-2265-2 | UST-9130 | UST-52119S |
| UST-2266-5 | UST-9133 | UST-52121S |
| UST-5293-5 | UST-9146I | UST-52124 |

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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 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 Lauren Hefner at [phone].

Sincerely Yours.

han DOK for

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(K) Number (if known): Device Name:

Indications For Use:

Aloka Prosound F75

The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal, Trans-rectal, Musculo-skeletal, Gynecological and Neonatal Cephalic applications.

The device is not indicated for Ophthalmic applications.

Prescription Use_ P (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 Device Evaluation (ODE)

Aushad D.K.

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110207

Page 1 of 1

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1.3.1

#### Diagnostic Ultrasound Indications for Use Form Prosound F75 .

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

| | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | | | See Note 1 | |
| Abdominal | | N | N | N | | N | | | See Note 1 | |
| Intra-operative (specify) | | N | N | N | | N | | | See Note 1 | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | N | N | N | | N | | | See Note 1 | |
| Neonatal Cephalic | | N | N | N | | N | | | See Note 1 | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | | | See Note 1, 2 | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | | | See Note 1 | |
| Transvaginal | | N | N | N | | N | | | See Note 1 | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | | | See Note 1 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | N | N | N | | N | | | See Note 1 | |

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

Additional Comments: Mixed mode operation includes: Note I- B/M, B/PWD, M/CD, B/CWD, B/CD/CWD Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder..)

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

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

---

(Division Sign-Off)

510K K110207

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#### Diagnostic Ultrasound Indications for Use Form UST-567 (K041916)

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

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
|----------------------------------|---|---|---|-----|-----|--------------------------|----------------------|------------------------------|-----------------------|-----------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | N | N | N | | N | | | See Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | | | See Note 1 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | | | See Note 1 | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |

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

Additional Comments: Combined includes Note 1: B/M, B/WD, M/CD, B/CD/PWD

Applications: Small Parts: ( breasts, 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)

(Division Sign-Off)

510K K110207

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#### Diagnostic Ultrasound Indications for Use Form UST-675P (K992663)

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

| | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | | | See Note 1 | |
| Transvaginal | | P | P | P | | P | | | See Note 1 | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | | | | | | | | | |

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

Additional Comments: Combined includes Note 1: BM, 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)

Mihail D. O'Brien
(Division Sign-Off)

510K K110207

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#### Diagnostic Ultrasound Indications for Use Form ASU-1010 (K043196)

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

| | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | | | See Note 1 | |
| Abdominal | | P | P | P | | P | | | See Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal- | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | P | | P | | | See Note 1 | |

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

Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

No br. 10 Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K Kilox22

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

#### Diagnostic Ultrasound Indications for Use Form UST-2265-2 (K012080)

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

| | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | P | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: | | | | | | | | | | | |

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

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

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

*(Division Sign-Off)*

Division of Radiological Devices Office of In Vitro Division of Alakological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K110267

45

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#### Diagnostic Ultrasound Indications for Use Form UST-2266-5 (K963616)

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

| | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | N | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: | | | | | | | | | | | |

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

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

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110267

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

#### Diagnostic Ultrasound Indications for Use Form UST-5293-5 (K003739)

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

| | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | See Note 1, 2 | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |

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

Additional Comments: Combined includes Note 1: BM, BPWD, MCD, 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)

(Division Sign-Off)

510K. K110207

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

#### Diagnostic Ultrasound Indications for Use Form UST-5411 (K043196)

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

| | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | P | | P | | | See Note 1 | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | | | See Note 1 | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | | | See Note 1 | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: | | | | | | | | | | | |

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

Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD

Applications: Small Parts: (breasts, testes, thyroid ... )

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Preseription Use (Per 21 CFR 801.109)

48

(Division Sign-Off)

510K K110207

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

.

510(K)

#### Diagnostic Ultrasound Indications for Use Form UST-5415 (K043196)

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

| | Modes of operation | | | | | | | | | | |
|-------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | N | N | N | | N | | | See Note 1 | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | | | See Note 1 | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | N | N | | N | | | See Note 1 | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: | | | | | | | | | | | |

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

Additional Comments: Combined includes Note 1: BM, BIPWD, MICD, BICD/PWD

Applications: Small Parts: (breasts, 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)

(Division Sign-Off)

510K K110207

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

#### Diagnostic Ultrasound Indications for Use Form UST-9118 (K992663)

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

| | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | | | See Note 1 | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | P | P | P | | P | | | See Note 1 | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | P | | P | | | See Note 1 | |

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

Additional Comments: Combined includes: 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)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110267

50

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#### Diagnostic Ultrasound Indications for Use Form UST-9130 (K043196)

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

| Clinical Application | Modes of operation | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | | | See Note 1 | |
| Abdominal | | P | P | P | | P | | | See Note 1 | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: Gynecological | | P | P | P | | P | | | See Note 1 | |

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

Additional Comments: Combined includes: 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)

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110207

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

## Diagnostic Ultrasound Indications for Use Form UST-9133 (K060059)

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

| | Modes of operation | | | | | | | | | | |
|----------------------------------|--------------------|---|---|-----|-----|--------------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler<br>(CD) | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | P | | | See Note 1 | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | | P | | | See Note 1 | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | |…