(17 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description is limited to ultrasound probes for a portable imaging system.
No
The probes are intended for "diagnostic ultrasound imaging or fluid flow analysis," which indicates a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the probes are "intended for diagnostic ultrasound imaging or fluid flow analysis."
No
The device description explicitly states that the device is a "Probe" intended for use with a "portable ultrasound imaging system," indicating it is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts with the body directly to produce images or analyze flow within the body.
- Device Description: The description confirms it's a "portable ultrasound imaging system." Ultrasound imaging is an in vivo (within the living body) diagnostic technique, not an in vitro (outside the living body) diagnostic technique.
- Lack of IVD Characteristics: IVD devices typically involve testing samples of biological material (blood, urine, tissue, etc.) outside the body to diagnose conditions. This device does not mention any such sample handling or analysis.
Therefore, based on the provided information, this device is an ultrasound imaging system used for in vivo diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes 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.
For Terason Model 2000 Portable Ultrasound System with various transducers: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
- Ophthalmic
- Fetal
- Abdominal
- Intra-operative (Spec.), (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.), (Superfic)
- Intra-luminal
- Cardiac Adult, Pediatric, Trans-esoph. (Cardiac)
- Peripheral vessel
Mode of Operation: B, M, PWD, CWD, Color Dopp, Comb. Modes, Other (Harmonic Imaging (HI), ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy, transvaginal biopsy, infertility monitoring of follicle development, amniocentesis).
Includes uses in military field settings in addition to hospital/clinic settings.
Product codes
90 IYN, IYO, ITX
Device Description
The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system. Technical specifications for the Model 810C4, and 10LAP4 Probes with the Model 2000 are as follows:
| Model | 8IOC4 | 8IOLA | 10LAP4 |
|---|---|---|---|
| Frequency/ | 6.0 MHz | 7.5 MHz | 7.0 MHz |
| # Elements | 128 | 128 | 128 |
| Array type | Curved | Linear | Linear |
| Pitch (mm) | 0.32 | 0.30 | 0.30 |
| Elevation width (mm | 5.0 | 5.0 | 5.0 |
| Geometric focus (mm) | 25 | 25 | |
| Azimuth radius (mm | 40 | N/A | N/A |
| Azimuth length (mm | 50.0 | 38.4 | 38.4 |
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.), (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.), (Superfic), Intra-luminal, Cardiac (Adult, Pediatric, Trans-esoph.), 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)
TERATECH 10V5, Philips LI9-5, Philips CT8-4, Philips LAP L9-5
Reference Device(s)
K961459, K991671, K994373, K002003, K011224, K992595, K010883, K012191, K030191, K040840
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
6043278
DEC 1 3 2004
510(k) Summary for TERATECH Model 810C4, 810L4, and 10LAP4 Probes
SPONSOR 1.
Teratech Corporation 77-79 Terrace Hall Rd. Burlington, MA 01803
Contact Person: Charles F. Hottinger, Ph.D., RAC, Regulatory Affairs Consultant
Telephone: 206-780-7945
Date Prepared: November 5, 2004
2. DEVICE NAME
Proprietary Name: TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes Common/ Usual Name: Diagnostic Ultrasound Transducer
Classification Name:
Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX)
3. PREDICATE DEVICES
| Subject Device | Predicate 1 | Predicate 2 |
|---|---|---|
| 8IOLA | Philips LI9-5 | TERATECH 10V5 |
| 8IOC4 | Philips CT8-4 | TERATECH 10V5 |
| 10LAP4 | Philips LAP L9-5 |
The Philips probes are marketed for use with the Philips HDI 5000; that system has been cleared in following 510(k) submissions, among possibly others: K961459, K991671, K994373, K002003, and K011224.
The TERATCH predicate probes, as well as the subject devices, are used with the TERATECH Model 2000 portable imaging system. This system has been cleared under the following 510(k) submissions: K992595,
Page 4.2-4
1
K010883, K012191, K030191, and K040840.
INTENDED USE ರ್.
The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes 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 ર-
The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are intended for use with the Model TERATECH2000, a portable ultrasoundimaging system. Technical specificationsfor the Model 810C4, and 10LAP4 Probes with the Model 2000 are as follows:
| Model | 8IOC4 | 8IOLA | 10LAP4 |
|---|---|---|---|
| Frequency/ | 6.0 MHz | 7.5 MHz | 7.0 MHz |
| # Elements | 128 | 128 | 128 |
| Array type | Curved | Linear | Linear |
| Pitch (mm) | 0.32 | 0.30 | 0.30 |
| Elevation width (mm | 5.0 | 5.0 | 5.0 |
| Geometric focus (mm) | 25 | 25 | |
| Azimuth radius (mm | 40 | N/A | N/A |
| Azimuth length (mm | 50.0 | 38.4 | 38.4 |
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are substantially equivalent to the above cited Philips transducers, which are currently in commercial distribution in the United States. The TERATECH Model 810C4, 81OL4, and 10LAP4 Probes are believed to be identical in mechanical design and materials to the respective Philips, and are intended for the same clinical applications.
2
4.3 INDICATIONS FOR USE
.
The TERATECH Model 8IOC4, 8IOL4, and 10LAP4 Probes are intended for the uses described in
the for the filiance of adjustical From is provided below I he TEKATECH MOGELBIOCS, STOCH, and 10EM IST is I v is provided below.
the Diagnostic Ultrasound Indications For Use Form is provided below.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized bird-like design with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
TERATECH Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K043278
Trade Name: Terason (Teratech) Model 2000 Portable Ultrasound System and Teratech Model 8IOC4, 8IOL4, 10LAP4 Probes 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: November 22, 2004 Received: November 26, 2004
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 rear 20, 1770, and vith 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 may also rovisions 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 1 the Terason (Teratech) Model 2000 Portable Ultrasound System, as described in your premarket notification:
Transducer Model Number
Teratech Model 8IOC4 Teratech Model 8IOL4 Teratech Model 10LAP4
4
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be If your device to such additional controls. Existing major regulations affecting your device can be found in the Sublest to suen additions. 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 I least be advisou that 1221 b 1804at your device complies with other requirements of the Act or any I DA mas made a adversions 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) er N Fart 801); good manally; 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 I mis occernmination of ourselearance 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by the Ornee of Gomphanes that in the 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
5
Page 3 – Mr. Job
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
6
| System: | Terason Model 2000 Portable Ultrasound | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | (see comments) | |||||||
| 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 | |||
| Dopp | Comb. | |||||||
| Modes | Other | |||||||
| Ophthalmic | Ophthalmic | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Fetal4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Abdominal4: | P1 | P2,4 | P2,4 | P2,4 | P3 | P2,4 | ||
| Intra-operative (Spec.)3,4 | P1 | P2 | P2 | P2 | P3 | P2 | ||
| Intra-operative (Neuro) | P3 | P3 | P3 | P3 | P3 | P3 | ||
| Laparoscopic | N | N | N | N | N | N | ||
| Pediatric4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Small Organ (Thyroid, | |||||||
| Breast, Testes, etc.)3,4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Neonatal Cephalic4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Adult Cephalic4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Trans-rectal: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Trans-vaginal: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Musculo-skel. (Superfic)4: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Intra-luminal | ||||||||
| Other (Specify) | P1 | P1 | ||||||
| Cardiac Adult | P1 | P2 | P2 | P2 | P2 | P2 | ||
| Cardiac | Cardiac Pediatric | P1 | P2 | P1 | P2 | P1 | P1 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral vessel4: | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P1,4 | ||
| Peripheral | ||||||||
| Vessel | Other (Specify) |
Terason Model 2000 Portable Ultrasono System_
N= new indication: P= previously cleared by FDA; E= added under Appendix E
V= new indication; P= previously clearce by FDA; E= added thour Applerior C
Includes Color Doppler (CD), Directional Power Doppler (OPD), and (non-directional) Power Doppler
B+M: B+PWD; B+CD; B+DPD; B+PD.
Harmonic Imaging (HI)
Harmonic Imaging (HI)
Includes ultrasound guidance for placement of needles, catheters.
Abdominal organs and peripheral vessel.
" Abdominal organs and periorient of needles, catheles, catheres, cayosurgery, and brechytherepy
' lockes und guidance of transvaglial biopsy. Inforlik, morely, and breany deny deny delay delay dela
" Includes uitane of transvaglial biopsy. Inferlily monitor development.
"Includes guidance of amniocentesis, infertility monitoring of follicle development."
System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
" System uses previously cleared under K012191.
· System uses praviously cleared under K010883.
· System uses previously cleared under K030191.
System uses previously cleared under K040840.
े System uses previously cleaned under K040840.
Includes uses in milltary field settings in addition to hospitalicinic settings.
{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU
(FEESE DO NOT WRITE BECOW THE BROOM PHO DATE Of Device Evaluation
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescipion Use (Per 2
Daniel b. Legron
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KD43278
1 2/09/04 TERATECH Corp. 510(k) Teratech Model 8IOC4, 810L4, and 10LAP4 Probes
7
Tarason Model 2000 Portable Ultrascund System System:
BIOC4 Transducer: Intended Use: Diagnostic ultraging 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 | |||
| Dopp | Comb. | |||||||
| Modes | Other | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal* | ||||||||
| Abdominal*: | N* | N* | N* | |||||
| Intra-operative (Spec.) | N | N | N | N* | N* | N* | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | 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 | ||||||||
| 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
Includes Color Doppier (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, cathelers
Abdominal organs and peripheral vessel.
Indudes ultrasound guidance for placement of needles, cather of felicle development
Includes ultrasound guidance of transvaginal bloosy, infectility montantonograph
- Includes guidance of amniocentesis, infertility monitoring of follicle development.
micudes unistophe of variates, infrilly moltong of folloc development.
Addes guismer ef anince in the monthing of folloce development.
Addional Comments P: uses previousl
under K030191
Urban, non-metro
for regular uses in military field settings, in addition to hospital/clinic settings.
Includes uses in military lield settings in addition to hospitalicing 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)
Daniel A. Bergman
51
TERATECH Corp. 510(k) 1 2/09/04 Teratech Model 810C4, 810L4, and 10LAP4 Probes
8
| System: | Terason Model 2000 Portable Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | 8I0L4 | ||||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | Specific | B | M | PWD | CWD | Color | |||
| Dapp' | Comb. | ||||||||
| Modes' | Other' | ||||||||
| (Track I Only) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal' | |||||||||
| Abdominal': | |||||||||
| Intra-operative (Spec.) a | N' | N' | N' | N' | N' | N' | |||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric': | ||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) 4 : | |||||||||
| Neonatal Cephalic": | |||||||||
| Adult Cephalic": | |||||||||
| Trans-rectal': | |||||||||
| Trans-vaginal': | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.)': | |||||||||
| Musculo-skel. (Superfic)": | |||||||||
| 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
V= new Indication; P= previously cleared by FDA; E= saded under Appendix E
lincludes 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.
Abdominal organs and peripheral vessal.
Indudes ultrasound guldance for placement of needies, cathelers, cryosurgery, and brachytherapy
"Includes ultrasound guidance of transvaginal bloosy, informations of follicie development.
System uses previously cleared under K992505 with 3 Milze development
System uses previously cleared under K992505 with 3 Mitz Model L3 (Linear).
System uses previously cleared under K012191.
System uses previously cleared under K010883.
· System uses previously cleared under K030191.
Includes uses in military field settings in addition to hospitaliclinic settings.
(PLEASE DO NOT WRITE BELOW THIS LINEA to HOSpitation a Catalys.
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)
David R. Seymore
(Division Sign-Off) Division of Re and Radiological Det 510(k) Number
TERATECH Corp. 510(k) 1 2/09/04 Teratech Model 810C4, 810L4, and 10LAP4 Probes
9
| System: | Terason Model 2000 Portable Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | 10LAP4 | |||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Dopp | Comb. | |||||||
| Modes | Other | |||||||
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal: | ||||||||
| Intra-operative (Spec.): | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | N | N | N | N | N | N | ||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | 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 | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral vessel: | ||||||||
| Peripheral | Other (Specify) |
on Model 2000 Portable Utraspund System -
N= new indication; P= previously cleand by FDA; E= added under Appendired
l= new indication; Pe previously desired by FDF E= added under Apperionely Power Doppler.
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directlonal)
· B+M; B+PWD; B+CD; B+DPD; B+PD.
Harmonic Imaging (HI)
" Includes ultrasound guidance for placement of needles, cathelers.
Abdominal organs and peripheral vessel.
° Abdominal organizat of needles cathelers, cathelers, axpsurgery, and brachyherapy
' lnekdes titance dransmit of necility moritorial
- Includes ultrasound evidence of transvaginal biopsy, infertility monitoring or IUI/IVF de
- Includes evidence of amniocentesis, infertility monitoring or follicle development.
¹System uses previously cleared under K982505 with 5 Mhz Model L3-101
2 System uses previously cleared under K012191.
System uses proviously deared under K0106B3. 2
· System uses previously cleared under K030191.
Includes uses in military field settings in addition to hospitalicinic settings. Includes uses in mlitary field actings in addition to nosphareines sellings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE IF NEEDED)
Concurrence of Canter for Devices and Radiological Health, Office of Device Evaluation
Concerner Starter (B = 01 SED =01 100) Prescription Use (Per 21 CFR 801.109)
David A. Lippson
(Division Sign-Off) eproductive, Abdomin Division of and Radi 510(k) Numb
12/09/04 TERATECH Corp. 510(k) Teratech Model 810C4, 810C4, and 10LAP4 Probes