(17 days)
No
The document describes improvements to the ultrasound beamforming engine and software for workflow and ease of use, but does not mention AI or ML.
No
Explanation: The device is described as a general purpose Ultrasound System intended for evaluation by ultrasound imaging or fluid flow analysis, not for therapeutic intervention.
Yes
The intended use explicitly states evaluation by ultrasound imaging or fluid flow analysis of the human body for specific clinical applications, which is a diagnostic purpose.
No
The device description explicitly states it is a "general purpose Ultrasound System" and mentions "improved transducer acoustic arrays" and an "ultrasound beam forming engine," which are hardware components. While software improvements are mentioned, the device is clearly a hardware-based ultrasound system with accompanying software.
Based on the provided information, the Teratech Corporation Terason™ t3200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves imaging the internal structures and functions of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the technical aspects of the ultrasound system, such as transducers, beam forming, and software for imaging and workflow.
- Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Terason™ t3200 is an imaging device used to visualize the body itself.
N/A
Intended Use / Indications for Use
The Teratech Corporation Terason™ t3200 is a general purpose Ultrasound. System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow anaiysis of the human body. Specific clinical applications and exam types include: Fetal; Abdominal; Intra-operative (abdominal, thoracic and PV); Laparosopic; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skelėtal Conventional and Superficial; Cardiac (adult & pediatric); Peripheral Vascular.
Product codes
IYO, ITX, IYN
Device Description
The Terason™ t3200 is a modified version of the Echo/t3000 Ultrasound System. The modifications include improved transducer acoustic arrays, an improvement in the ultrasound beam forming engine to improve the bandwidth of the receive signal processing capability and improvements in the software for workflow and ease of use of the system.
The design and construction of the Terason™ t3200 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.
The differences between the Terason™ t3200 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:
- The engine has a slight modification in the custom beamformer chip (as . compared to the Terason Echo/t3000 system) that provides for improved filtering of the return signal for wider bandwidth and better resolution across the whole image field.
- The ultrasound application software has been modified to improve the user workflow and ease of use. The screen layout has been modified, and the user controls have been changed for better efficiency for the targeted exam types.
- Transducers have been improved by utilizing new acoustic arrays.
15L4: Same housing construction as the 12L5 and 7L3 used on the previously cleared Echo/t3000 ultrasound system. The acoustic array is new with improved sensitivity and wider bandwidth than the 12L5.
6C1: Same material construction as used on the 15L4. The acoustic array is new with improved sensitivity and wider bandwidth than the previously cleared 5C2 used on the Echo/t3000 ultrasound system.
16HL7: Same identical transducer as used on the previously cleared Echo/t3000 ultrasound system (labeled 12HL7 on the Echo / t3000).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV), Pediatrics, Small Organ (Breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Peripheral Vascular.
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, Adult
Intended User / Care Setting
Qualified physician.
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)
The Terason™ t3200 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).
- IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- IEC 62366, Medical Devices: Application of usability engineering to . medical devices.
- IEC60601-1-6, Medical Electrical Equipment Part 1-6: General . requirements for safety- Collateral standard: Usability
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2; General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- NEMA UD 3 Acoustic Output Display Terason t3200 Ultrasound System User Guide (16-3033)
- Biocompatibility Tests, ISO 10993 Part 5 and Part 10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Terason™ Echo/t3000 Ultrasound System (K080234)
Reference Device(s)
Not Found
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
KI10020
510(k) Summary
Teratech Corporation
Terason™ t3200 Ultrasound System
JAN 2 0 2011
1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Charles F. Hottinger, Ph.D, RAC, Regulatory Affairs Consultant Telephone: 206-780-7945
Date Prepared: November 1, 2010
2. Device Name
Proprietary Name: Terason™ t3200 Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Diagnostic Ultrasound Transducer Classification Name:
(21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
3. Predicate Device
Terason™ Echo/t3000 Ultrasound System (K080234)
4. Intended Use
The Teratech Corporation Terason™ t3200 is a general purpose Ultrasound. System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult
1
Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
5. Device Description
The Terason™ t3200 is a modified version of the Echo/t3000 Ultrasound System. The modifications include improved transducer acoustic arrays, an improvement in the ultrasound beam forming engine to improve the bandwidth of the receive signal processing capability and improvements in the software for workflow and ease of use of the system.
6. Technology Characteristics
The design and construction of the Terason™ t3200 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.
The differences between the Terason™ t3200 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:
- The engine has a slight modification in the custom beamformer chip (as . compared to the Terason Echo/t3000 system) that provides for improved filtering of the return signal for wider bandwidth and better resolution across the whole image field.
- · The ultrasound application software has been modified to improve the user workflow and ease of use. The screen layout has been modified, and the user controls have been changed for better efficiency for the targeted exam types.
- . Transducers have been improved by utilizing new acoustic arrays.
15L4: Same housing construction as the 12L5 and 7L3 used on the previously cleared Echo/t3000 ultrasound system. The acoustic array is new with improved sensitivity and wider bandwidth than the 12L5.
6C1: Same material construction as used on the 15L4. The acoustic array is new with improved sensitivity and wider bandwidth
2
than the previously cleared 5C2 used on the Echo/t3000 ultrasound system.
16HL7: Same identical transducer as used on the previously cleared Echo/t3000 ultrasound system (labeled 12HL7 on the Echo / t3000).
B1. Non Clinical Tests
The Terason™ t3200 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).
- IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- o Intertek Test Record Number 100116897BOX-003
- IEC 62366, Medical Devices: Application of usability engineering to . medical devices.
- o Intertek Project: 100116897BOX-005
- IEC60601-1-6, Medical Electrical Equipment Part 1-6: General . requirements for safety- Collateral standard: Usability
- o Intertek Project: 100116897BOX-006
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2; General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests
- o IEC60601-1-2 Intertek Test Record Number, 100116897BOX-013
- o IEC60601-1-2 Intertek Test Record Number, 100116897BOX-010
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- o Transducer Model 6C1: Intertek Report Number IEC60601-2-37 t3200 6C1: 100116897BOX-008
3
- Transducer Model 15L4: Intertek Report Number IEC60601-2 o 37 t3200 15L4: 100116897BOX-007
- o Transducer Model 16HL7: Intertek Report Number IEC60601-2-37 t3200 16HL7: 100116897BOX-009
- . NEMA UD 3 Acoustic Output Display Terason t3200 Ultrasound System User Guide (16-3033)
- Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- o Biocompatibility reports for all transducers (Attachments M-O of original submission)
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings, rendered in a stylized, minimalist design.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Teratech Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JAN 2 0 201
Re: K110020
Trade/Device Name: TERASON™ t3200 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: December 30, 2010 Received: January 3, 2011
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 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 TERASON™ t3200 Ultrasound System, as described in your premarket notification:
Transducer Model Number
6C1 16HL7 1514
5
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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely Yours.
Mary S. Parker
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
6
Indications for Use Form
. "
JAN 2 0 2011
510(k) Number (if known): K110020 Device Name: _ Terason Ultrasound Systems Indications for Use:
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow anaiysis of the human body. Specific clinical applications and exam types include: Fetal; Abdominal; Intra-operative (abdominal, thoracic and PV); Laparosopic; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal Conventional and Superficial; Cardiac (adult & pediatric); Peripheral Vascular.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Peake
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 510020
Page 1 of 1
Daniel A. Blumenthal Professor
7
System: TERASON™ t3200 Ultrasound System______________________________________________________________________________________________________________________________________________
| Clinical Application | Mode of Operation | Otherc | ||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppa | Comb. | |||||||
| Modesb | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetalf | N | N | N | N | N | N | ||
| Abdominalb: | N | N | N | N | N | N | ||
| Intra-operative (Spec.)d,e | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | |||||||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | N | N | N | N | N | N | ||
| Neonatal Cephalicc: | ||||||||
| Adult Cephalicc: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginal6: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)c: | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic)c: | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesselb: | N | N | N | N | N | N | |
| Other (Specify) |
Transducer: (see comments)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
a Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).
6 B+M; B+PWD; B+CD; B+OPD; B+PD
° Harmonic Imaging (HI)
0 Incl. ultrasound guidance for placement of needles,
catheters
° Abdominal organs and peripheral vessel.
I Incl. ultrasound guidance for piacement of needles,
catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility
monitoring of follicle development.
4 incl. guidance of amniocentesis, infertility monitoring of
follicle development.
' Incl. stress echo.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
N= new indication
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Slatt
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k).
Page 1 of __
8
TERASON™ t3200 Ultrasound System____________________________________________________________________________________________________________________________________________ System:
Transducer: 6C1
10
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Otherc | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track Only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppa | Comb. | ||||||||
| Modesb | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetaln | N | N | N | N | N | N | |||
| Abdominalc: | N | N | N | N | N | N | |||
| Intra-operative (Spec.)d,e | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetai | |||||||||
| Imaging | |||||||||
| & Other | Pediatricc: | N | N | N | N | N | N | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.)d: | |||||||||
| Neonatal Cephalicc: | |||||||||
| Adult Cephalicc: | |||||||||
| Trans-rectalf: | |||||||||
| Trans-vaginalc: | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.)c: | N | N | N | N | N | N | |||
| Musculo-skel. (Superfic)c: | N | N | N | N | N | N | |||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | N | N | N | N | N | N | |||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vesselc: | N | N | N | N | N | N | ||
| Other (Specify) |
Includes Color Dopp. (CD), Directional Power Dopp. N= new indication
(DPD), and (non-directional) Power Dopp. (PD).
0 B+M: B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
0 Incl. ultrasound guidance for placement of needles,
catheters
° Abdominal organs and peripheral vessel.
I Incl. ultrasound guidance for placement of needles,
catheters, cryosurgery, and brachytherapy
6 Incl. ultrasound guidance of transvaginal biopsy, infertility
monitoring of follicle development.
" Incl. guidance of amniocentesis, infertility monitoring of
follicle development.
Incl. stress echo.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Statts
Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety 510(k
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
9
TERASON™ t3200 Ultrasound System System:
16HL7 Transducer:
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 | ||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| (Track I Only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetaln | ||||||||
| Abdominalc: | ||||||||
| Intra-operative (Spec.)a,e | N | N | N | N | N | N | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | |||||||
| Small Organ (Thyroid, | ||||||||
| Breast. Testes. etc.)d: | N | N | N | N | N | N | ||
| Neonatal Cephalicc: | ||||||||
| Adult Cephalicc: | ||||||||
| Trans-rectall: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)o: | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic)o: | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesselo: | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| a Includes Color Dopp. (CD), Directional Power Dopp. | N= new indication |
Includes Color Dopp. (CD), Directional Power Dopp.
(DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+DPD; B+PD
° Harmonic Imaging (HI)
Harmonic Imaging (HI)
dial, without spectral equivalent
d incl. ultrasound guidance for placement of needles,
catheters
· Abdominal organs and peripheral vessel.
Incl. ultrasound guidance for placement of needles,
catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility
monitoring of follicie development.
" Incl. guidance of amniocentesis, infertility monitoring of
follicle development.
Incl. stress echo.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastet
Division Sign Office of in Vit Evaluation
510(k) K110020
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
10
TERASON™ t3200 Ultrasound System System:
Transducer: 15L4
.
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 | |||||||
| Fetaln | ||||||||
| Abdominalo: | N | N | N | N | N | N | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | N | N | N | N | N | N | |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | N | N | N | N | N | N | ||
| Neonatal Cephalicc: | ||||||||
| Adult Cephalicc: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | N | N | N | N | N | N | ||
| Musculo-skel. (Superfic)d: | N | N | N | N | N | N | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesselo: | N | N | N | N | N | N | |
| Other (Specify) |
4 Includes Color Dopp. (CD), Directional Power Dopp. N= new indication ·
(DPD), and (non-directional) Power Dopp. (PD).
6 B+M; B+PWD; B+CD; B+DPD; B+PD
°Harmonic Imaging (HI)
4 incl. ultrasound guidance for piacement of needles,
catheters
్ Abdominal organs and peripheral vessel.
inci. ultrasound guidance for placement of needles,
catheters, cryosurgery, and brachytherapy
9 Incl. ultrasound guidance of transvaginal biopsy, infertility
monitoring of follicie development.
1 incl. guidance of amnìocentesis, infertility monitoring of
follicle development.
' Incl. stress echo.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mays. Posth
Division Sign-Q Office of In Vitro Diagnostic Device Evaluatio
Page 1 of ____________________________________________________________________________________________________________________________________________________________________