K Number

Device Name

TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM

Manufacturer

TERATECH CORP.

Date Cleared

2003-01-29

(8 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The TERASON™ Model 2000/BAS Portable Ultrasound Systems are 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 Description

Technical specifications for the TERASON™ Model 2000/BAS Portable Ultrasound Systems are as follows: System: Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4), Frame rate: 15 - 58 fps (Imaging only), Ultrasound lines/frame: 128, Fields of View: 2.5 - 24 cm, External Video Output: Composite Video, VGA Monitor, Liquid-Crystal Display: 10.4" XVGA TFT, Size: Width: 11.6", Height: 9.3", Depth: 1.65", Weight: Laptop Computer 4.84 lb., Smart Probe 10 oz. Electrical: External Power: Input: 115-250 VAC, Output: 19 VDC @ 4A, Battery: Li-Ion battery pack (4 cells), Leakage Current: 50 μΑ maximum, Primary Breakdown Voltage: greater than 1500 V AC, Safety Standards: IEC 601-1, UL 2601 Can/CSA C22.2 601.1, Protection Class: Class I: per IEC 601-1, Degree of Protection: Type BF: per IEC 601-1. Environmental: Mechanical Shock: EC 68-2-27 compliant (Smart Probe only), Mechanical Vibration: Sinusoidal: IEC 68-2-6 (Smart Probe only), Drop Test (to concrete): 3 feet (Smart Probe only), Operating Temperature: 0 to 50 C (Smart Probe only), Humidity: 20 to 80% RH, non-condensing, Water Resistance: Transducer array watertight to the strain relief, Altitude (Pressure): 63 Kpa to 101.3 Kpa. Storage: Temperature: -25 to 60°C (Smart Probe only), -40 to 70°C (GETAC CA25), Humidity: 15 to 98% RH, non-condensing (Smart Probe only). Refer to computer manufacturer's documentation for relevant environmental specifications.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K012191, K994373, K993624

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a standard portable ultrasound system with technical specifications related to hardware, electrical, and environmental parameters. There is no mention of AI, ML, deep learning, or any related computational techniques for image processing or analysis. The description focuses on the physical and functional aspects of the ultrasound device itself.

Therapeutic

No
The device is intended for "diagnostic ultrasound imaging or fluid flow analysis," which means it is used to identify medical conditions, not to treat them.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components such as transducers, a laptop computer, a liquid-crystal display, and electrical specifications, indicating it is a physical ultrasound system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that uses physical principles (ultrasound waves) to create images or measure flow within the body.
Device Description: The technical specifications detail the components and performance of an ultrasound system, including transducers, frame rates, fields of view, and electrical/environmental parameters. These are all characteristic of an imaging device used on the body.
Input Imaging Modality: The input modality is explicitly stated as "Ultrasound." Ultrasound is an imaging technique applied externally or internally to the body, not a method for analyzing samples in vitro (outside the body).
Anatomical Site: The extensive list of anatomical sites indicates the device is used to examine various parts of the human body directly.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes that would be performed in vitro.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic purposes. This ultrasound system operates by interacting with the body directly to produce images and measurements.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

IYN, IYO, ITX

Device Description

Technical specifications for the TERASON™ Model 2000/BAS Portable Ultrasound Systems are as follows:

System
Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4)
Frame rate: 15 - 58 fps (Imaging only)
Ultrasound lines/frame: 128
Fields of View: 2.5 - 24 cm
External Video Output: Composite Video, VGA Monitor
Liquid-Crystal Display: 10.4" XVGA TFT
Size: Width: 11.6" Height: 9.3" Depth: 1.65"
Weight: Laptop Computer 4.84 lb. Smart Probe 10 oz

Electrical
External Power: Input: 115-250 VAC, Output: 19 VDC @ 4A
Battery: Li-Ion battery pack (4 cells)
Leakage Current: 50 microA maximum
Primary Breakdown Voltage: greater than 1500 V AC
Safety Standards: IEC 601-1, UL 2601 Can/CSA C22.2 601.1
Protection Class: Class I: per IEC 601-1
Degree of Protection: Type BF: per IEC 601-1

Environmental
Mechanical Shock: EC 68-2-27 compliant (Smart Probe only)
Mechanical Vibration: Sinusoidal: IEC 68-2-6 (Smart Probe only)
Drop Test (to concrete): 3 feet (Smart Probe only)
Operating Temperature: 0 to 50 C (Smart Probe only)
Humidity: 20 to 80% RH, non-condensing
Water Resistance: Transducer array watertight to the strain relief
Altitude (Pressure): 63 Kpa to 101.3 Kpa

Storage
Temperature: -25 to 60°C (Smart Probe only) -40 to 70°C (GETAC CA25)
Humidity: 15 to 98% RH, non-condensing (Smart Probe only)
Refer to computer manufacturer's documentation for relevant environmental specifications.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging

Anatomical Site

Human body, Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K012191, K994373, K993624

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you 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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

KD30191

JAN 2 9 2003

510(k) Summary for TERASON™ Model 2000/BAS Portable Ultrasound System

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

| Contact Person: | Charles F. Hottinger, Ph.D., RAC,
Regulatory Affairs Consultant |
|-----------------|--------------------------------------------------------------------|
| Telephone: | 408-741-1006 |

Date Prepared: · December 16, 2002

1. DEVICE NAME
  Proprietary Name:

Common/Usual Name: Classification Name:

TERASON™ Model 2000/BAS Portable Ultrasound Systems Ultrasound System and Transducers Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90 IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90 IYO) Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX)

3. PREDICATE DEVICES

Teratech Corp. TERASON™ 2000 Handheld Ultrasound System (1): K012191 Date Cleared: July 26, 2001
ATL HDI™ 1500 Diagnostic Ultrasound System and Transducers (2): K994373
- Date Cleared: May 24, 2000
Dymax Corp. Site-Rite 3 Ultrasound Scanner (3) K993624 Date Cleared: November 10, 1999

INTENDED USE 4.

DEVICE DESCRIPTION 5.

Technical specifications for the TERASON™ Model 2000/BAS Portable Ultrasound Systems are as follows:

System

| System | Transducer frequencies: (8EC4, 8L4) |
|----------------------|----------------- | | Frame rate: | | Ultrasound lines/frame: | | Fields of View: | | External Video Output: | | Liquid-Crystal Display: | | Size: Width: | | Height: | | Depth: | | Weight: Smart Probe | 4.84 lb.
10 oz |
| Electrical | | | External Power: Output: 19 VDC @ 4A |
| | Battery: | | Leakage Current: | | Primary Breakdown Voltage: | | Safety Standards: Can/CSA C22.2 601.1 |
| | Protection Class: | | Degree of Protection: | Environmental | | | Mechanical Shock: (Smart Probe only) |
| | Mechanical Vibration: (Smart Probe only) |
| | Drop Test (to concrete): (Smart Probe only) | | Operating Temperature: | 2-4 MHz (4C2 and 4V2), 4-8 MHz
-----------------------|-----------------------------------------------|
| 15 - 58 fps (Imaging only) |
| 128 |
| 2.5 - 24 cm |
| Composite Video, VGA Monitor |
| 10.4" XVGA TFT |
| 11.6" |
| 9.3" |
| 1.65" |
Laptop Computer
| |
| Input: 115-250 VAC,
| Li-Ion battery pack (4 cells) |
| 50 μΑ maximum |
| greater than 1500 V AC |
| IEC 601-1, UL 2601
| Class I: per IEC 601-1 |
| Type BF: per IEC 601-1 |
| |
| EC 68-2-27 compliant
| Sinusoidal: IEC 68-2-6
| 3 feet
|
| 0 to 50 C (Smart Probe only) |

Humidity:	20 to 80% RH, non-condensing
Water Resistance:	Transducer array watertight to the strain relief
Altitude (Pressure):	63 Kpa to 101.3 Kpa

Storage

Temperature:

Humidity:

-25 to 60°C (Smart Probe only) -40 to 70°C (GETAC CA25) 15 to 98% RH, non-condensing (Smart Probe only)

Refer to computer manufacturer's documentation for relevant environmental specifications.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The TERASON™ Model 2000/BAS Portable Ultrasound Systems are substantially equivalent to the products listed in (3.) above, since the subject device has intended uses and modes of operation which are a subset of those of the predicates.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the symbol, and the word "DEPARTMENT" is at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2003

TERATECH Corporation % Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 5112-1891

Re: K030191

Trade Name: Model Terason 2000/BAS Portable Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: January 20, 2003 Received: January 21, 2003

Dear Ms. Danielson:

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 Model Terason 2000/BAS Portable Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C2
4V2
8L4

8EC4

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 (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.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Page 3 - Ms. Danielson

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Lippman

Image /page/5/Picture/4 description: The image contains a black and white graphic. The graphic appears to be a stylized signature or abstract design. It consists of a series of connected, curved lines that form a repetitive, wave-like pattern.

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

Enclosure(s)

Terason Model 2000, BAS Portable Ultrasound Systems

Transducer: (see comments)

System:

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal	P1Nh	P2Nh	P2Nh		P2Nh	P2Nh	P2Nh
	Abdominal:	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Intra-operative (Spec.)e	Nd	Nd	Nd		Nd	Nd	Nd
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric:	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Small Organ (Thyroid,
Breast, Testes, etc.):	P2Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Neonatal Cephalic:	P1	P2	P2		P2	P2	P2
	Adult Cephalic	P1	P2	P2		P2	P2	P2
	Trans-rectal	P2,3Nf	P3Nf	P3Nf		P3Nf	P3Nf	P3Nf
	Trans-vaginal	P2,3Ng	P3Ng	P3Ng		P3Ng	P3Ng	P3Ng
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P2Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Musculo-skel. (Superfic)	P2Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P1	P2	P2		P2	P2	P2
	Cardiac Pediatric	P1	P2	P2		P2	P2	P2
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel:	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Other (Specify)

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

8 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.

Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear);

P : uses previously cleared under K012191; P : uses previously cleared under K010883.

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 Reproductive, Abde and Radiological Devices 510(k) Number

Terason Model 2000, BAS Portable Ultrasound Systems

Transducer:	4C2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetal	P1Nn	P2Nn	P2Nn		P2Nn	P2Nn	P2Nn
	Abdominal	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P1Nd
	Small Organ (Thyroid,
Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

9 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)

System:

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 guidance of amniocentesis, infertility monitoring of follicle development.

Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P : uses previously cleared under K012191

Includes use 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)

David A. Wyman

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

System: Terason Model 2000, BAS Portable Ultrasound Systems Transducer: 4V2

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

Clinical Application		Mode of Operation
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetal	P1Nh	P2Nh	P2Nh		P2Nh	P2Nh	P2Nh
	Abdominal	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Small Organ (Thyroid,
Breast, Testes, etc.)
	Neonatal Cephalic	P1	P2	P2		P2	P2	P2
	Adult Cephalic	P1	P2	P2		P2	P2	P2
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent)
	Musculo-skel. (Superfic)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P1	P2	P2		P2	P2	P2
	Cardiac Pediatric	P1	P2	P2		P2	P2	P2
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

3 Includes Color Doppler (CD), Directional Power Doppler (DPD, and (non-directional) Power Doppler. 0B+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.

Additional Comments: P1: uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P2: uses previously cleared under K012191.

Includes use 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 Reproductive, Abdominal, and Radiological Devices
510(k) Number	K030191

TERATECH Corp. 510(k)
1/10/03
CONFIDENTIALTERATECH Corp. 510(k) 11 0/03 TERASON Model 2000/BAS Portable Ultrasound Systems CONFIDENTIAL Page 4.3-4

System: Terason Model 2000/BAS Portable Ultrasound Systems Transducer: 814 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Clinical Application CWD Color Comb. Other Specific B PWD General M Dopp® Modes® (Track I Only) (Tracks I & III) Ophthalmic Ophthalmic Fetal P'Nº P2Ng Peng bena P2Nd P2Ng Abdominal: Na NG Na Na Na No Intra-operative (Spec.)e Intra-operative (Neuro) Laparoscopic Ping bend P2Nº P2Nº P=Nº B-Nº Pediatric: Fetal P2Ng P2Ng beng Péng P-Ng P-Nº Imaging Small Organ (Thyroid, & Other Breast, Testes, etc.): P ps Ps p² Neonatal Cephalic: P P pr PT P pz pz p2 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) P2Ng P-Ng P-Nº P2Nº PEN® P-Nº Musculo-skel. (Convent.) Musculo-skel. (Superfic) p-No P-No P