ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM

K111227 · Aloka Co., Ltd. · IYN · May 13, 2011 · Radiology

Device Facts

• Record ID: K111227
• Device Name: ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Aloka Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

Device Story

The Aloka SSD-3500 Ver. 7.8 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, specialized controls, and a display. It supports various modes including B, M, PWD, and Color Doppler, and mixed modes (B/M, B/PWD, M/CD, B/CD/PWD). Used by qualified physicians in clinical settings, the system aids in diagnostic evaluation across multiple anatomical applications. The device provides real-time visualization and analysis, supporting clinical decision-making through standard ultrasound imaging techniques.

Clinical Evidence

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

Technological Characteristics

Mobile diagnostic ultrasound console. Supports B, M, PWD, and Color Doppler modes. Includes various transducers (e.g., UST-533, UST-676P, ASU-1003). Conforms to medical device safety standards for acoustic output, biocompatibility, and EMC. Quality systems conform to 21 CFR 820, ISO 9001:2000, and ISO 13485.

Indications for Use

Indicated for ultrasound evaluation of small parts (breast, testes, thyroid), abdominal, cardiac, peripheral vascular, fetal, intra-operative (liver, pancreas, gall bladder, cardiac), trans-vaginal, trans-rectal, gynecological, pediatric, laparoscopic, and neonatal cephalic applications. Not indicated for ophthalmic use. Prescription use only.

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-3500 Ver. 7.0 Diagnostic Ultrasound System (K060059)

Reference Devices

• UST-533 (K032875)
• UST-534 (K032875)
• UST-535 (K042540, K032875)
• UST-536 (K060059)
• UST-568 (K003739)
• UST-579T-7.5 (K963616)
• UST-670P-5 (K954022)
• UST-672-5/7.5 (K992663)
• UST-676P (K023996)
• UST-677P (K060059)
• UST-978-3.5 (K963616)
• UST-979-3.5 (K963616)
• UST-984-5 (K972465)
• UST-987-7.5 (K992663)
• UST-990-5 (K003739)
• UST-995-7.5 (K992663)
• ASU-1003 (K020668)
• ASU-1009 (K060059)
• UST-5268P-5 (K992663)
• UST-5293-5 (K003739)
• UST-5298 (K003739)
• UST-5299 (K003739)
• UST-5413 (K992663)
• UST-5524-7.5 (K963616)
• UST-5536-7.5 (K992663)
• UST-5542 (K003739)
• UST-5546 (K023996)
• UST-5548 (K032875)
• UST-5710-7.5 (K003739)
• UST-9101-7.5 (K003739)
• UST-9102-3.5 (K012253)
• UST-9102U-3.5 (K012253)
• UST-9104-5 (K003739)
• UST-9112-5 (K012253)
• UST-9121 (K003739)
• UST-9123 (K003739)
• UST-9124 (K003739)
• UST-9127 (K060059)
• UST-9128 (K032875)
• UST-9133 (K060059)
• UST-9136U (K043196)
• UST-MC11-8731 (K032875)

Submission Summary (Full Text)

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

K 111227
510(K)

# MAY 1 3 2011

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

Section a):

| 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: | 2/17/11 |
| 2. Device Name: | Aloka SSD-3500 Ver. 7.8 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 SSD-3500 Ver. 7.0 Diagnostic Ultrasound System K060059, (90-IYN, ITX, IYO)<br>( A device currently in commercial distribution) |
| 4. Device Description: | The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis<br>system. It consist of a mobile console that provides acquisition, processing and display capability.<br>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<br>Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative<br>(Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal<br>Cephalic applications.<br>The device is not indicated for Ophthalmic applications. |
| 6.Comparison w/ Predicate Device: | The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the<br>current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key<br>safety and effectiveness features, and has the same intended uses and basic operating modes as<br>the predicate device. |
| Section b): | |
| 1. Non-clinical Tests: | The device and its transducers have been evaluated for acoustic output, biocompatibility,<br>cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and<br>mechanical safety, and have been found to conform with applicable medical device safety<br>standards. |
| 2. Clinical Tests: | None Required. |
| 3. Conclusion: | Intended uses and other key features are consistent with traditional clinical practices, FDA<br>guidelines and established methods of patient examination. The design, development and<br>quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO<br>13485 quality systems. The device conforms to applicable medical device safety standards<br>and compliance is verified through independent evaluation with ongoing factory<br>surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness<br>performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-3500 Ver. 7.8 |

Ultrasound System and its transducers are substantially equivalent with respect ﻟﻠ lagino to safety and effectiveness to its predicate and other currently cleared Aloka systems.

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

Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

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

## MAY 1 3 2011

Re: K111227

Trade/Device Name: Aloka SSD-3500 Ver. 7.8 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: April 24, 2011 Received: May 2, 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 SSD-3500 Ver. 7.8 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

| UST-533 | UST-676P | ASU-1003 | UST-5536-7.5 |
|---------------|-------------|--------------|--------------|
| UST-534 | UST-677P | ASU-1009 | UST-5542 |
| UST-535 | UST-978-3.5 | UST-5268P-5 | UST-5546 |
| UST-536 | UST-979-3.5 | UST-5293-5 | UST-5548 |
| UST-568 | UST-984-5 | UST-5298 | UST-5710-7.5 |
| UST-579T-7.5 | UST-987-7.5 | UST-5299 | UST-9101-7.5 |
| UST-670P-5 | UST-990-5 | UST-5413 | UST-9102-3.5 |
| UST-672-5/7.5 | UST-995-7.5 | UST-5524-7.5 | UST-9102U-3. |

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

| TITT 010 | 110T 0100 | 1100 0100 | 0 円 へ |
|--------------------------------------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| T T CLETT | 105 010 | TOTT<br>A 1 4 4 4 4 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
| 1 10 70 0 1<br>11<br>--------------- | 700 000 | TTAT<br>019 | |

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 Shahram Vaezy at [phone].

Sincerely Yours,

Michael D Ó hAnnracháin

Mary S. Pastel, Sc.D. 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): {くししょえ 7

Device Name:

Aloka SSD-3500 Ver. 7.8

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, Intraoperative (Cardiac), Trans-vaginal, Transrectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications.

The device is not indicated 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 Device Evaluation (ODE)

Michael O'Hara
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Hadlolugiour Dovice Evaluation and Safety

510K K11227

Page 1 of 1

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1.3.1

#### Diagnostic Ultrasound Indications for Use Form SSD-3500 Ver. 7.8

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>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | | | | See Below | | |
| Intra-operative (specify) | | P | P | P | | | | | See Below | | |
| Intra-operative (cardiac) | | N | N | N | | | | | See Below | | |
| Pediatric | | P | P | P | | | | | See Below | | |
| Small Organ (specify) | | P | P | P | | | | | See Below | | |
| Neonatal Cephalic | | P | P | P | | | | | See Below | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | | | | See Below | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | | | | See Below | | |
| Transvaginal | | P | P | P | | | | | See Below | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | | | | See Below | | |
| Laparoscopic | | P | P | P | | | | | See Below | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other: Gynecological | | P | P | P | | | | | See Below | | |

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

Additional Comments: Mixed mode operation includes: B/M, B/PWD, M/CD, B/CD/PWD

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

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

ncurrence 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. h 111227

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

# Diagnostic Ultrasound Indications for Use Form

### UST-533 (K032875)

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>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | | | | See Below | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | P | | | | | See Below | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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: B/M, B/PWD, M/CD, B/CD/PWD

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)

///A.D.O.K
(Division Sign-Off)

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

510K K111227

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

#### Diagnostic Ultrasound Indications for Use Form UST-534 (K032875)

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>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | E | E | E | | | | | See Below | | |
| 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 | | | | | | | | | | | |

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.

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)

DÓK
(Division Sign-Off)

Division of Radiological Dev Office of In Vitro Dia

K11227
510K

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

#### Diagnostic Ultrasound Indications for Use Form UST- 535 (K042540, K032875))

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 | | | | | | | | | | |
| Intra-operative (specify) | | N | N | N | | | | | See Below | |
| Intra-operative (cardiac) | | N | N | N | | | | | See Below | |
| 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 | | | | | | | | | | |

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.

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

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)

Office of In no unting and

510K KIIIAA¬

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

#### Diagnostic Ultrasound Indications for Use Form UST-536 (K060059)

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 | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | P | P | P | | | | | See Below | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | P | P | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| 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: B/M, B/PWD, M/CD, B/CD/PWD.

Applications: 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)

Discian of Radionorica Office of In Vi

510K K111227

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

#### Diagnostic Ultrasound Indications for Use Form UST-568 (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 | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | E | E | E | | | | | See Below | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | E | E | E | | | | | See Below | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | | | | See Below | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional<br>Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |

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.

Applications: 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)***

on of Harmingical Device Office of In

510K K 11227

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

#### Diagnostic Ultrasound Indications for Use Form UST-579T-7.5 (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) | | P | P | P | | | | | See Below | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | P | P | P | | | | | See Below | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| fransesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | | | | See Below | | |
| 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: B/M, B/PWD, M/CD, B/CD/PWD.

Applications: 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)

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510K KIIII227

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

#### Diagnostic Ultrasound Indications for Use Form UST-670P-5 (K954022)

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) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | | | | See Below | |
| Transvaginal | | P | P | P | | | | | See Below | |
| 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- 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 UST-672-5/7.5 (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 | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | | | | See Below | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |

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

Additional Comments: Combined includes: 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)

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510K KIIIO27

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

#### Diagnostic Ultrasound Indications for Use Form UST-676P (K023996)

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) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | | | | See Below | |
| Transvaginal | | P | P | P | | | | | See Below | |
| 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: BM, BPWD, 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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510K KIIIAA

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

#### Diagnostic Ultrasound Indications for Use Form UST-677P (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 | Amplitude<br>Velocity | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | | | | See Below | | |
| Transvaginal | | P | P | P | | | | | See Below | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other: Gynecological | | | | | | | | | | | |

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/PW.

(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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Division of Radiological Office of In Vitro Diagnostic

510K KII227

50

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

#### Diagnostic Ultrasound Indications for Use Form UST-978-3.5 (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 | | P | P | P | | | | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | See Below | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| 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: 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 K11222

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

#### Diagnostic Ultrasound Indications for Use Form UST-979-3.5 . (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 | | P | P | P | | | | | | |
| Abdominal | | P | P | P | | | | | See Below | |
| Intraoperative (specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | |…