TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
Device Facts
| Record ID | K030191 |
|---|---|
| Device Name | TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM |
| Applicant | Teratech Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 29, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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 Story
Portable ultrasound system comprising a laptop computer and smart probe; captures acoustic signals via transducers (frequencies 2-4 MHz, 4-8 MHz); transforms inputs into B-mode, M-mode, PWD, and Color Doppler images; displays output on 10.4" XVGA TFT screen; operated by clinicians in hospitals, clinics, or military field settings; provides real-time visualization for diagnostic imaging and interventional guidance (e.g., needle placement); aids clinical decision-making through anatomical and fluid flow assessment.
Clinical Evidence
Bench testing only. No clinical data provided. System performance verified through acoustic output measurements, electrical safety (IEC 601-1, UL 2601), and environmental testing (mechanical shock, vibration, drop tests).
Technological Characteristics
Portable ultrasound system; laptop-based architecture with smart probe; 10.4" XVGA display; Li-Ion battery powered; Class I, Type BF protection per IEC 601-1; transducer frequencies 2-4 MHz and 4-8 MHz; external video output (VGA/Composite); watertight transducer arrays; connectivity via standard video interfaces.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in clinical applications including fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel. Includes ultrasound guidance for needle/catheter placement, cryosurgery, brachytherapy, amniocentesis, and infertility monitoring. Used in hospital, clinic, and military field settings.
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
- TERASON™ 2000 Handheld Ultrasound System (K012191)
- ATL HDI™ 1500 Diagnostic Ultrasound System and Transducers (K994373)
- Dymax Corp. Site-Rite 3 Ultrasound Scanner (K993624)
Reference Devices
- 3 MHz Model L3 (K992505)
- K010883
Related Devices
- K113156 — SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · Nov 15, 2011
- K012191 — TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES · Teratech Corp. · Jul 26, 2001
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K142197 — ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 · Konica Minolta, Inc. · Nov 21, 2014
- K151060 — Ultrasound System SONIMAGE HS1 · Konica Minolta, Inc. · Jun 5, 2015
Submission Summary (Full Text)
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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,<br>Regulatory Affairs Consultant |
|-----------------|--------------------------------------------------------------------|
| Telephone: | 408-741-1006 |
Date Prepared: · December 16, 2002
- 2. 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
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#### INTENDED USE 4.
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 5.
Technical specifications for the TERASON™ Model 2000/BAS Portable Ultrasound Systems are as follows:
## System
| <b>System</b> | Transducer frequencies: | 2-4 MHz (4C2 and 4V2), 4-8 MHz<br>(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<br>Smart Probe | 4.84 lb.<br>10 oz |
| <b>Electrical</b> | | |
| | External Power: | Input: 115-250 VAC,<br>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<br>Can/CSA C22.2 601.1 |
| | Protection Class: | Class I: per IEC 601-1 |
| | Degree of Protection: | Type BF: per IEC 601-1 |
| <b>Environmental</b> | | |
| | Mechanical Shock: | EC 68-2-27 compliant<br>(Smart Probe only) |
| | Mechanical Vibration: | Sinusoidal: IEC 68-2-6<br>(Smart Probe only) |
| | Drop Test (to concrete): | 3 feet<br>(Smart Probe only) |
| | Operating Temperature: | 0 to 50 C (Smart Probe only) |
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| 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".
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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<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 | 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,<br>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<br>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
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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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>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<br>Imaging<br>& Other | Pediatric | P1Nd | P2Nd | P2Nd | | P2Nd | P2Nd | P1Nd |
| | Small Organ (Thyroid,<br>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<br>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
{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<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>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<br>Imaging<br>& Other | Pediatric | P1Nd | P2Nd | P2Nd | | P2Nd | P2Nd | P2Nd |
| | Small Organ (Thyroid,<br>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<br>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
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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
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| System: | Terason Model 2000, BAS Portable Ultrasound Systems | | | | | | | |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------|------|------|-----|-----------------|-----------------|--------|
| Transducer:<br>8EC4 | | | | | | | | |
| 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>Doppaa | Comb.<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>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) | | | | | | | |
| Peripheral<br>Vessel | 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 _
