TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO

K080234 · Teratech Corp. · IYO · Feb 14, 2008 · Radiology

Device Facts

• Record ID: K080234
• Device Name: TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
• Applicant: Teratech Corp.
• Product Code: IYO · Radiology
• Decision Date: Feb 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Device Story

TERASON™ ECHO/t3000 is a diagnostic ultrasound system derived from the TERATECH Model 2000. It provides B-mode, M-mode, PWD, CWD, and Color Doppler imaging. Key features include ECG triggering, stress echo, and LV dyssynchrony assessment. Used in clinical and military field settings by healthcare professionals for imaging and fluid flow analysis. The system processes ultrasound signals to produce real-time images, aiding clinicians in diagnostic decision-making and interventional guidance. Benefits include non-invasive visualization of internal structures and blood flow, supporting clinical assessment of cardiac and general anatomy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Diagnostic ultrasound system with 128:128 transmit/receive beamforming channels. Supports CWD, ECG trigger, and stress echo. Compatible with various transducers (AcuNav 8F/10F, UST-534, V5Ms). Operates via pulsed echo imaging. Connectivity includes standard ultrasound interfaces.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Includes ultrasound guidance for needles, catheters, cryosurgery, brachytherapy, amniocentesis, and follicle monitoring. Supports stress echo and stress transsphenoidal applications.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Acuson Cypress Ultrasound System (K021497)
• Acuson Sequoia Diagnostic Ultrasound System Signature II (K022567)
• ALOKA SSD-3500 Ultrasound System (K021497)

Submission Summary (Full Text)

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

K080234
1of2

FES 14

# 510(k) Summary TERATECH Corporation TERASON™ Ultrasound System with Continuous Wave (CW) Doppler

- 1. SPONSOR
TERATECH Corporation 77-79 Terrace Hall Rd. Burlington, MA 01803

Charles F. Hottinger, Ph.D., RAC, Contact Person: Regulatory Affairs Consultant

Telephone: [phone]

Date Prepared: August 22, 2007

- 2. DEVICE NAME
Proprietary Name:

TERASON™ ECHO/t3000 Ultrasound System with Stress Echo

Common/Usual Name: Diagnostic Ultrasound System

Classification Name:

Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)

### PREDICATE DEVICES 3.

Acuson Cypress Ultrasound System K021497 (Stress Echo)

Acuson Sequoia Diagnostic Ultrasound System Signature II K022567 (TEE-V5M)

ALOKA SSD-3500 Ultrasound System (UST-536, equiv. To UST-534) K021497

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

### 4. INTENDED USE

The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

### ട. DEVICE DESCRIPTION

The TERASON™ ECHO/t3000 Ultrasound System with Stress Echo comprises two versions of the TERATECH Model 2000 Imaging System introduced under K051334..

| | TERATECH<br>2000 | TERASONTM<br>t3000 | TERASONTM<br>Echo |
|-----------------------------------------------|------------------|--------------------|-------------------|
| Transmit: Receive<br>Beam forming<br>Channels | 128:64 | 128:64 | 128:128 |
| CW Doppler | No | Yes | Yes |
| ECG Trigger | No | Yes | Yes |
| Tissue Doppler | No | No | Yes |
| LV Dyssynchrony<br>Assessment | No | No | Yes |
| Stress Echo | | Yes | Yes |

### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The TERASON™ Ultrasound System Stress Echo function is substantially equivalent to that with the Acuson Cypress Ultrasound, which is currently in commercial distribution in the United States. Since it is identical in modes of operation, and intended for the same clinical applications, as described in this submission.

The TERASON™ Ultrasound System will be marketed with the Acuson V5Ms and ALOKA UST-534, which have previously been cleared under 510(k) submissions by the respective manufacturers.

{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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.

FEB 1 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TERATECH Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K080234

Trade/Device Name: TERASON™ Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO and ITX Dated: January 29, 2008 Received: January 30, 2008

Dear Mr. Job:

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 TERASON™ Ultrasound System, as described in your premarket notification:

## Transducer Model Number

AcuNav 8F & 10F 4V2 UST-534 V SMs

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

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 898. 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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

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

Sincerely yours,

Vorutn Wh Whz

Growancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------|------|------|-----|----------------|-----------------|--------|
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetaln | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominald: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)d,e,j | N4 | N4 | N4 | | N4 | N4 | N4 |
| | Intra-operative (Neuro) | P5 | P5 | P5 | | P5 | P5 | P5 |
| | Laparoscopic | P6 | P6 | P6 | | P6 | P6 | P6 |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Neonatal Cephalicd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 |
| | Adult Cephalicd: | P1,4 | P2,4 | P2,4 | P7 | P2,4 | P2,4 | P2,4 |
| | Trans-rectali: | P2-4 | P3-4 | P3-4 | P7 | P3-4 | P3-4 | P3-4 |
| | Trans-vaginalg: | P2-4 | P3-4 | P3-4 | | P3-4 | P3-4 | P3-4 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Musculo-skel. (Superfic)d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N1 | N2 | N2 | N1 | N2 | N2 | N2 |
| | Cardiac Pediatric | N1 | N2 | N2 | N1 | N2 | N2 | N2 |
| | Trans-esoph. (Cardiac) | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Other (Specify) | | | | | | | |

TERASON™ Ultrasound System System:

Transducer:(see comments)

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

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

ී Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

b B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

° Abdominal organs and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Includes stress echo.

I Includes stress transsphenoidal.

1 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

2 System uses previously cleared under K012191

3 System uses previously cleared under K010883.

* System uses previously cleared under K030191.

ీ System uses previously cleared under K040840.

6 System uses previously cleared under K043278.

7 System uses previously cleared under K051334

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) (Division Sign-Off

Division of Reuroductive. A

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

System: TERASON™ Ultrasound System

# Transducer: AcuNav 8F & 10F

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

| Clinical Application | | Mode of Operation | | | | | | Otherc |
|-----------------------------|--------------------------------------------------|-------------------|---|-----|-----|----------------|----------------|--------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>Modesb | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetalh | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e,i | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adulti | | | | | | | |
| | Cardiac Pediatrici | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Catheter) | N | N | N | N | N | N | N |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

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

4 Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

° Abdominal organs and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Includes stress transsphenoidal.

' Includes stress echo.

1 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

2 System uses previously cleared under K012191.

3 System uses previously cleared under K010883.

1 System uses previously cleared under K030191.

ీ System uses previously cleared under K040840.

6 System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluati Prescription Use (Per 21 CFR 801.109)

Evaluation

Division Sign-Off)

510(k) Number

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

System: TERASON™ Ultrasound System

Transducer: 4V2

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------------------------|-------------------|------|------|-----|----------------|----------------|--------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetald | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominald: | P1,4 | P2,4 | P2,4 | P/ | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)d,e | P4,7 | P4,7 | P4,7 | | P4,7 | P4,7 | P4,/ |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1,4 | P2,4 | P2,4 | P/ | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | P1 | P2 | P2 | P/ | P2 | P2 | P2 |
| | Adult Cephalicd: | P1 | P2 | P2 | P/ | P2 | P2 | P2 |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adulti | N1 | N2 | N2 | N/ | N2 | N2 | N2 |
| | Cardiac Pediatrici | N1 | N2 | N2 | N/ | N2 | N2 | N2 |
| | Trans-esoph. (Cardiac)i | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

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

් Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

ీ Abdominal organs and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follice development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Includes stress echo.

Includes stress transsphenoidal.

1 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

² System uses previously cleared under K012191.

3 System uses previously cleared under K010883.

4 System uses previously cleared under K030191.

3 System uses previously cleared under K0408491.
8 System uses previously cleared under K040840.
6 o

6 System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

(Division Sign pructive. Abdominal

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

| TERASON™ Ultrasound System<br>System: | |
|--------------------------------------------------------------------------------------------------|---------------------|
| Transducer: UST-534 | |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | ( Mode of Operation |

| Clinical Application<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppaa | Comb<br>Modesb | Otherc |
|----------------------------------------|--------------------------------------------------|---|---|-----|-----|-----------------|----------------|--------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging & Other | Fetalh | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e,j | N | N | N | | N | N | N |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectall: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult' | | | | | | | |
| | Cardiac Pediatric' | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

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

4 Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

0 B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

& Abdominal organs and peripheral vessel.

' Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

I Includes stress transsphenoidal.

' Includes stress echo.

System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

2 System uses previously cleared under K012191.

3 System uses previously cleared under K010883.

1 System uses previously cleared under K030191.

్ System uses previously cleared under K040840.

° System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evalua Prescription Use (Per 21 CFR 801.109)

ice Evaluation

(Division Sign off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------|---|-----|-----|----------------|----------------|--------|
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetaln | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e: | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicc: | | | | | | | |
| | Adult Cephalicc: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adulti | | | | | | | |
| | Cardiac Pediatrici | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

TERASON™ Ultrasound System System:

Transducer: V5Ms

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

² Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8 B+M; B+PWD; B+CD; B+DPD; B+PD.

°Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal organs and peripheral vessel.

' Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

ി Includes ultrasound biologic plassinon biogsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

' Includes stress echo.

I Includes stress transsphenoidal.

1 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

2 System uses previously cleared under K552005
3 October uses previously cleared under K012191.

3 System uses previously cleared under K010883.

4 System uses previously cleared under K010083.
* System uses previously cleared under K030191.

5 System uses proviously cleared under K060191.
* System uses previously cleared under K040840.

8 System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

e Evaluation
(Division Sign-Off)

Division of Reproduction. Andominal and Radiological Devices 510(k) Number