DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

K113613 · Shantou Institute of Ultrasonic Instuments · IYN · Jun 15, 2012 · Radiology

Device Facts

• Record ID: K113613
• Device Name: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
• Applicant: Shantou Institute of Ultrasonic Instuments
• Product Code: IYN · Radiology
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac, trans-vaginal, trans-rectal and peripheral vascular applications.

Device Story

SIUI Apogee 1200 is a digital color Doppler ultrasound imaging system. It processes ultrasonic pulsed echo signals via various transducers (linear, convex, phased array, endocavity) to generate 2D (B-mode), M-mode, Doppler (PWD/CWD), Color (CFM), and 3D images. Used in clinical settings by healthcare professionals for diagnostic imaging and measurements of abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, and reproductive structures. System features include cine review, image zoom, measurement/calculation tools, and image storage/printing. Output is displayed on-screen for clinician interpretation to support clinical decision-making and patient diagnosis. Benefits include non-invasive visualization of internal anatomy and blood flow.

Clinical Evidence

Bench testing only. Device performance verified per FDA guidance 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' (2008). Acoustic output measured per NEMA UD 2:2004. Safety testing conducted per IEC 60601-1, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Digital ultrasound system supporting linear, convex, phased array, and endocavity transducers. Operating modes: B, M, PWD, CWD, Color Doppler, 3D. Safety standards: IEC 60601-1 (electrical safety), ISO 10993 (biocompatibility). Acoustic output compliant with NEMA UD 2.

Indications for Use

Indicated for diagnostic ultrasonic imaging in abdominal, pediatric, small organ (thyroid, testes, breast), musculo-skeletal, cardiac, peripheral vascular, trans-vaginal, and trans-rectal applications. Supports B, M, PWD, CWD, Color Doppler, and 3D imaging modes.

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

• Ultrasonix Ergononix 500 Ultrasound Scanner (K042326)

Submission Summary (Full Text)

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

K113613

SIUI Apogee 1200 Digital Color Doppler Ultrasound Imaging System

# 510(k) Summary

JUN 1 5 2012

This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is:

1. 510(k) Owner:

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road, Shantou, Guangdong 515041, China Tel: [phone] Fax: [phone]

#### Contact Person:

Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: November 30, 2011

#### 2. Device/Trade Name:

Apogee 1200 Digital Color Doppler Ultrasound Imaging System

#### Classification Name:

Regulatory Class: II

Ultrasonic Pulsed Doppler Imaging System 90-IYN (per 21 CFR 892.1550) Ultrasonic Pulsed Echo Imaging System 90-IYO (per 21 CFR 892.1560) Diagnostic Ultrasound Transducer 90-ITX (per 21 CFR 892.1570)

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

#### 3. Predicate Device:

The subject device is substantially equivalent to the device currently having FDA 510(k) clearance Ultrasonix Ergononix 500 Ultrasound Scanner (K042326) with respect to intended use, principles of operation and technological characteristics.

#### 4. Device Description:

The SIUI Apogee 1200 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD/CWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

#### Intended Use: 5.

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac, trans-vaginal, trans-rectal and peripheral vascular applications.

#### 6. Safety Considerations:

The Apogee 1200 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.

#### 7. Conclusion:

The conclusions drawn from testing of the Apogee 1200 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device.

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

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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

JUN 1 5 2012

Ms. Flower Cai Assistant to Director Shantou Institute of Ultrasonic Instruments Co., Ltd (SIUI) International Department 77 Jinsha Road SHANTOU GUANGDONG 515041 CHINA

Re: K113613

Trade/Device Name: Apogee 1200 Digital Color Doppler Ultrasound Imaging System w/ Convex Array C3LC, Linear Array L8LC, Convex Array C5LF, Phased Array P3FC, Endocavity V6LC, Endocavity Biplane ECBP

Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: · IYN, IYO, and ITX Dated: June 11, 2012 Received: June 11, 2012

Dear Ms. Cai:

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 Apogee 1200 Digital Color Doppler Ultrasound Imaging System w/Convex Array C3LC, Linear Array L8LC, Convex Array C5LF, Phased Array P3FC, Endocavity V6LC, Endocavity Biplane ECBP, as described in your premarket notification:

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

#### Transducer Model Number

Convex Array C3LC Linear Array L8LC Convex Array C5LF

Phased Array P3FC Endocavity V6LC Endcavity Biplane ECBP

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 Jeffrey Ballyns at [phone].

Sincerely Yours,

uchael D. O'Hern for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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

# Indications for Use Statement

#### 510(k) Number (if known):

#### Device Name:

Apogee 1200 Digital Color Doppler Ultrasound Imaging System with

Convex Array C3LC Linear Array L8LC Convex Array C5LF Phased Array P3FC Endocavity V6LC Endocavity Biplane ECBP

#### Indications for Use:

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color ' Doppler and 3D imaging modes.

Prescription Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arad D. O'her
(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagnostic Device

510K

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

#### 3.1 System Indications for Use Form

#### System: Apogee 1200

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | N | N | N | | N | | N |
| | Abdominal | N | N | N | | N | | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | | |
| | Small Organ (Specify) | N | N | N | | N | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | | |
| | Trans-vaginal | N | N | N | | N | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | N | N | N | | N | | N |
| Cardiac | Cardiac Adult | N | N | N | N | N | | |
| | Cardiac Pediatric | N | N | N | N | N | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | | |
| | Other (Specify) | | | | | | | |

N = new indication: P = previously cleared by FDA; E = added under this appendix

* Other modes of operation include: 3-D Imaging;

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast

Presefiption Use (Per 21 CFR 801.109))

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113613

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

#### 3.2 Transducer Indications for Use Form

#### Transducer: Convex Array C3LC

| Clinical Application | | | Mode of Operation | | | | | |
|-----------------------------|------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | N | N | N | | N | | |
| | Abdominal | N | N | N | | N | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | N | N | N | | N | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

Michael D. O'Hara

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K 6113613

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

SIUI Apogee 1200 Digital Color Doppler Ultrasound Imaging System

### Diagnostic Ultrasound Indications for Use Form

# 3.3 Transducer Indications for Use Form

#### Transducer: Linear Array L8LC

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 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) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | N | N | N | | N | | |
| | Small Organ (Specify) | N | N | N | | N | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comments: Small organs include: Thyroid, Testes, Breast

Prescription Use (Per 21 CFR 801.109)

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

· · 510K

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

#### 3.4 Transducer Indications for Use Form

# Transducer: Convex Array C5LF

| Clinical Application | | | | Mode of Operation | | | | |
|---------------------------|----------------------------|---|---|-------------------|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | N | | | | | N |
| | Abdominal | | N | | | | | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal | Pediatric | | | | | | | |
| Imaging | Small Organ (Specify) | | | | | | | |
| & Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal | | | | | | | |
| | (Conventional) | | | | | | | |
| | Musculo-skeletal | | | | | | | |
| | (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | N | | | | | N |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (Specify) | | | | | | | |

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

* Other modes include: 3-D Imaging;

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Raciological Devices
Office of in Vitro Ori
1

Office of In Vitro Diaginostic Dev valuation and Safety 510k

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

### 3.5 Transducer Indications for Use Form

# Transducer: Phased Array P3FC

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | | |
| | Cardiac Pediatric | N | N | N | N | N | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Prescription Use (Per 21 CFR 801.109)

Aush D. Ok
(Division Sign-Off)

(Division of Radiological Devices Office of In Vitro Disagnostic Device Evaluation and Safety

510K K113613

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

#### 3.6 Transducer Indications for Use Form

### Transducer: Endocavity V6LC

| Clinical Application | | | Mode of Operation | | | | | |
|---------------------------|------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 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) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal | Pediatric | | | | | | | |
| Imaging | Small Organ (Specify) | | | | | | | |
| & Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | | |
| | Trans-vaginal | N | N | N | | N | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | N | N | N | | N | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (Specify) | | | | | | | |

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

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

Mhhal D. O'th
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K 1/36/3

510K

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

#### 3.7 Transducer Indications for Use Form

# Transducer: Endocavity Biplane ECBP

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | | |
| | Trans-vaginal | N | N | N | | N | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | N | N | N | | N | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (Specify) | | | | | | | |

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

Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801(109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113613