K Number

Device Name

TERATECH, MODEL 2000 IMAGING IMAGING

Manufacturer

TERATECH CORP.

Date Cleared

1999-11-10

(106 days)

Product Code

IYO

Regulation Number

892.1560

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular. Intended for use in military field settings in addition to hospital/clinic settings.

Device Description

The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe.

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

K903603, K914945, K946277

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging technology and image processing techniques (gamma correction, dynamic range, speckle noise reduction) which are not inherently AI/ML. There is no mention of AI, ML, deep learning, training data, test data, or performance metrics typically associated with AI/ML devices.

Therapeutic

No
The device is described as an ultrasound imaging system for diagnostic purposes, not for treating any condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

The device description explicitly states that the device consists of a laptop computer and a 3 MHz linear array ultrasonic probe, which are hardware components.

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 "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that images the internal structures of the body using ultrasound waves.
Device Description: The device is described as a "portable ultrasound imaging system".
Input Imaging Modality: The input is "Diagnostic Ultrasound".
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. This device operates in vivo (within the body) by emitting and receiving ultrasound waves.

The information provided clearly indicates that this is a diagnostic imaging device that works by interacting directly with the patient's body, not by analyzing samples in a lab setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular.

Product codes

90-IYO, 90-ITX

Device Description

The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe.

Technical specifications for the Model 2000 are as follows: System frequencies: 2-4 MHz, Frame rate: 15-30 fps (imaging only), Number of ultrasound lines per frame: 128, Fields of view: 2-27 cm, Mode of Operation: 2D imaging, Image display: Rectangular and trapezoidal, Video: S-VHS Output, External VGA Monitor, LCD size: 14.1", Gray shades: 256, Image magnification: 1X-4X, probe dependent, Image presentation: black/white, left/right, up/down, Image processing: gamma correction, dynamic range, speckle noise reduction, Input power: 115 VAC, A/C adapter rated @ 60 W, Power consumption:

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

K992505

510(k) Summary for TERATECH Model 2000 Imaging System

1. SPONSOR

Teratech Corporation 223 Middlesex Turnpike Burlington, MA 01803

Contact Person:	Alice Chiang, President
Telephone:	781-270-4143

July 26, 1999 Date Prepared:

2. DEVICE NAME

Proprietary Name:	TERATECH Model 2000 Imaging System
Common/Usual Name:	Diagnostic Ultrasound Imaging System
Classification Name:	Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO)
	Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX)

3. PREDICATE DEVICES

ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277)

4. INTENDED USE

The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging.

ട്. DEVICE DESCRIPTION

The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe. Technical specifications for the Model 2000 are as follows:

7/26/99

System frequencies:	2-4 MHz
Frame rate:	15-30 fps (imaging only)
Number of ultrasound lines
per frame:	128
Fields of view:	2-27 cm
Mode of Operation:	2D imaging
Image display:	Rectangular and trapezoidal
Video:	S-VHS Output, External VGA Monitor
LCD size:	14.1"
Gray shades:	256
Image magnification:	1X-4X, probe dependent
Image presentation:	black/white, left/right, up/down
Image processing:	gamma correction, dynamic range, speckle noise
reduction
Input power:	115 VAC, A/C adapter rated @ 60 W
Power consumption:	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 and additionally 809.10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97) . . be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internat address "http://www.fda.gov/cdrh/dsmamain.html" .

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

and

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

Dlagnostic Ultrasound Indications for Use Form Teratech Model 2000 Imaging System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N
Abdominal		N
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric		N
Small Organ(Specify)
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac		N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)

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

For use with 3 MHz Model L3 Transducer. Additional Comments: Intended for 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 CDRH, Office of Device Evaluation

Prescription Use (Per CFR 801.108)

Emil A. Severson

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

a comments paparticipal

... . ...:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

. . . . . .

Diagnostic Ultrasound Indications for Use Form 3 MHz Model L3 Transducer for Teratech Model 2000 Imaging System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N
Abdominal		N
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric		N
Small Organ(Specify)
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac		N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)

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

Intended for use in military field settings in addition to hospital/clinic Additional Comments: settings.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PADE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per CFR 801.108)

David A. Kyman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

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