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.

AI/ML Overview

The provided text for KD030191 is a 510(k) Summary for the TERASON™ Model 2000/BAS Portable Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices.

However, this document does not contain the type of detailed information typically found in a study proving a device meets specific performance acceptance criteria, especially for AI/algorithm-driven devices. This document is from 2003, predating the widespread use and regulatory requirements for AI in medical devices as we understand them today.

The document focuses on establishing substantial equivalence based on:

Intended Use: The TERASON™ 2000/BAS is intended for diagnostic ultrasound imaging or fluid flow analysis, for various clinical applications.
Technological Characteristics: It lists technical specifications such as transducer frequencies, frame rate, resolution, physical dimensions, electrical and environmental characteristics.
Comparison to Predicate Devices: It states that the device is substantially equivalent to previously cleared ultrasound systems (Teratech TERASON™ 2000, ATL HDI™ 1500, Dymax Site-Rite 3) because its intended uses and modes of operation are a subset of those predicates.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies, as these aspects are not present in the provided 510(k) summary.

The primary "acceptance criterion" demonstrated in this submission is substantial equivalence to legally marketed predicate devices, as assessed by the FDA based on the provided technical specifications and intended uses, rather than a performance study against predefined benchmarks.

The closest information related to "performance" would be the technical specifications listed, which are descriptive rather than performance metrics with acceptance limits.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose)

Acceptance Criterion (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Technical Specifications)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications.	Functions as an ultrasound system to perform diagnostic imaging for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel), including support for modes like B, M, PWD (Pulsed Wave Doppler), CWD (Continuous Wave Doppler), Color Doppler, and Combined Modes. It also includes "new indications" (N) and "previously cleared" (P) uses based on prior submissions.
Technological Characteristics: Specifications for image acquisition and display, system dimensions, electrical safety, and environmental robustness.	- 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: 11.6" W x 9.3" H x 1.65" D- Weight: Laptop 4.84 lb, Smart Probe 10 oz- Electrical Safety: IEC 601-1, UL 2601, Can/CSA C22.2 601.1 compliant; Class I, Type BF protection; max 50 μA leakage, primary breakdown >1500 V AC.- Environmental: EC 68-2-27 compliant for mechanical shock, IEC 68-2-6 for mechanical vibration (Smart Probe only); 3ft drop test (Smart Probe only); 0-50°C operating temperature (Smart Probe only); 20-80% RH humidity; watertight transducer array; 63-101.3 Kpa altitude.
Safety: Device must meet recognized safety standards.	Meets IEC 601-1, UL 2601, Can/CSA C22.2 601.1 standards for electrical safety. Acoustic output measurements are required post-clearance.
Effectiveness: Device is sufficiently effective for its intended diagnostic purpose comparable to predicates.	The device is deemed "substantially equivalent" to predicate devices, implying comparable effectiveness based on its technical characteristics and intended uses. No specific performance metrics (e.g., diagnostic accuracy, sensitivity, specificity) are provided for comparison in this summary document.

Regarding the other specific points, the document provides no information:

Sample size used for the test set and the data provenance: Not applicable or not provided. This document doesn't describe a specific performance study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable or not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standard ultrasound system, not an AI-driven image analysis tool requiring such studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a diagnostic imaging system operated by a human.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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

INTENDED USE 4.

DEVICE DESCRIPTION 5.

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

System

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 ComputerSmart Probe	4.84 lb.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 2601Can/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)

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

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.

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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

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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.

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

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".

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

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)

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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	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	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

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

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	ColorDoppa	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
FetalImaging& 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)
PeripheralVessel	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

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

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	ColorDoppa	CombModesb	Otherc
Ophthalmic	Ophthalmic
	Fetal	P1Nh	P2Nh	P2Nh		P2Nh	P2Nh	P2Nh
	Abdominal	P1Nd	P2Nd	P2Nd		P2Nd	P2Nd	P2Nd
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& 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)
PeripheralVessel	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

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

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<Nº P-Nº P-Nº P-Na Intra-luminal Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Trans-esoph. (Cardiac) Other (Specify) Peripheral Peripheral vessel: Ping P2Ng P2Nº P2Nº PENG P2N9 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.

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

"Harmonic Imaging (HI)

9 Includes ultrasound guidance for placement of needles, catheters.

e Abdominal organs and peripheral vessel

Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P4: uses previously cleared under K012191.

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)

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

David A. Syam

(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 03/19 1 510(k) Number

CONFIDENTIAL Page 4.3-6

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

System:	Terason Model 2000, BAS Portable Ultrasound Systems
Transducer:8EC4
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	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P2,3N1	P3N1	P3N1		P3N1	P3N1	P3N1
	Trans-vaginal	P2,3N9	P3N9	P3N9		P3N9	P3N9	P3N9
	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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

ª 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)

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

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

Additional Comments: P2: uses previously cleared under K012191;

P3: 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)

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

Daniel A. Leverson

(Division Sign-Off) (Division Orgential, Abdominal, and Radiological Devices 510(k) Number _

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.