(25 days)
The Teratech Corporation Terason™ uSmart3200T 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, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
The Terason™ uSmarl3200T ultrasound system is equivalent to the previously cleared version of the t3200 and t3000 Ultrasound Systems described in the following 510(k) submissions (K110020 and K112953). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.
The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11,5" backlit touch screen. The tablet dimensions (8,82"(H) x 12,64"(W) x 1,25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.
The provided document is a 510(k) Summary for the Terason™ uSmart3200T Ultrasound System, detailing its substantial equivalence to previously cleared devices. It focuses on regulatory compliance, safety, and performance characteristics rather than clinical study results establishing diagnostic accuracy against a ground truth.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy metrics). The document refers to compliance with safety and performance standards (e.g., IEC 60601-1) but not clinical performance acceptance criteria like sensitivity, specificity, or AUC against a ground truth.
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
However, based on the document, I can provide the following relevant information regarding the device's acceptance criteria and the study that proves its compliance with regulatory standards:
The device's acceptance criteria are primarily defined by compliance with established international and national standards for medical electrical equipment, including safety, usability, electromagnetic compatibility, and acoustic output. The "study" proving the device meets these criteria consists of specific non-clinical tests and reports generated by accredited testing laboratories (Intertek).
1. A table of acceptance criteria and the reported device performance (focused on technical compliance):
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| General Safety | IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety | Intertek Test Record Number 100825075BOX-001 (indicates compliance) |
| Usability | IEC 62366, Medical Devices: Application of usability engineering to medical devices | Intertek Project: 100825075BOX-004 (indicates compliance) |
| IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General requirements for safety- Collateral standard: Usability | Intertek Project: 100825075BOX-003 (indicates compliance) | |
| Electromagnetic Compatibility (EMC) | 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 | Intertek Test Record Number, 100933162BOX-017 (indicates compliance) |
| Specific Safety (Ultrasound) | IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment | Transducer Model 5C2A: Intertek Report 100825075BOX-006 (compliance) Transducer Model 12L5A: Intertek Report 100825075BOX-007 (compliance) Transducer Model 4V2A: Intertek Report 100825075BOX-005 (compliance) |
| Acoustic Output Display | NEMA UD 3 Acoustic Output Display | Terason uSmart3200T Ultrasound System User Guide (16-3301) (indicates adherence to display requirements) |
| Biocompatibility (Transducers) | ISO 10993 Part 5 and Part 10 | Biocompatibility reports for all transducers (indicates compliance) |
| Substantial Equivalence (General) | Comparison to predicate devices: Terason™ t3000 (K112953) and Terason™ t3200 (K110020) | The FDA's 510(k) clearance letter (K131209) states the device is "substantially equivalent" to predicate devices for the stated indications for use. |
| Indications for Use | General purpose ultrasound imaging and fluid flow analysis for specific clinical applications | The device supports Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular. |
Important Note: This document describes a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a previously cleared device. It does not typically involve new clinical efficacy studies with ground truth establishment in the way that, for example, a novel diagnostic AI algorithm would. The "performance" here refers to meeting established safety and performance standards for ultrasound devices, and demonstrating that changes from predicate devices (e.g., changing from laptop to tablet) do not raise new safety or effectiveness concerns.
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MAY 2 4 2013
510(k) Summary Teratech Corporation Terason™ uSmart3200T Ultrasound System
- Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Ben Chiampa, Quality Assurance and Requlatory Affairs Telephone: 781-270-4143 Date Prepared: March 21, 2013
2. Device Name
Proprietary Name: Terason™ uSmart3200T Uitrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer
(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 Devices
Terason™ t3000 Ultrasound System (K112953) and Terason™ t3200 Ultrasound System (K110020)
4. Device Description
The Terason™ uSmarl3200T ultrasound system is equivalent to the previously cleared version of the t3200 and t3000 Ultrasound Systems described in the following 510(k) submissions (K110020 and K112953). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.
The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11,5" backlit touch screen. The tablet dimensions (8,82"(H) x 12,64"(W) x 1,25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.
{1}------------------------------------------------
5. Intended Use
The Teratech Corporation Terason™ uSmart3200T 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, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
6. Technology Characteristics
The design and construction of the Terason™ uSmart3200T is similar to the Terason™ t3200 Ultrasound system. These systems utilize a tablet (or laptop) computer running Windows 7 to execute the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. For the uSmart3200T, the engine is housed in a compartment that is attached to the backside of the tablet computer.
The similarity and difference between the Terason™ uSmart3200T and the Terason 13200 Ultrasound System (the predicate device) include the following:
- The engines are the same with no modification in the custom beamformer chip . (as compared to earlier versions of Terason ultrasound systems) that provides for improved filtering of the return signal for wider bandwidth and better resolution across the entire image field.
- The ultrasound application software has been modified to improve the user . workflow and ease of use commensurate with a tablet application. The screen layout has been modified and the user controls have been changed for finger touch control to improve the efficiency for the targeted exam types.
Transducers: The Terason uSmart3200T and the BenQ UP200 will support 3 transducers. These transducers have been previously cleared.
- . 12L5A: Cleared in 510k submission K112953 (February 3, 2012)
- 5C2A: Cleared in 510k submission K112953 (February 3, 2012) .
- 4V2A: Cleared in 510k submission K112953 (February 3, 2012). .
The following provides additional details of the three transducers, presented in this submission, that were previously cleared.
- . 12L5A: equivalent indications for use, frequency settings, shape of transducer head and needle guide/software brackets. Same manufacturer, same acoustic array and patient contact materials.
- 5C2A: equivalent indications for use, frequency settings, and needle guide bracket / . software. Same manufacturer, same shape, same acoustic array and palient contact materials.
- 4V2A: equivalent indications for use, frequency settings, and needle guide bracket . / software. Same manufacturer, same shape, same acoustic array and palient contact materials.
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B1. Non Clinical Tests
The Terason™ uSmart3200T 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 100825075BOX-001.
- IEC 62366, Medical Devices: Application of usability engineering to medical ● devices.
- o Intertek Project: 100825075BOX-004.
- IEC60601-1-6, Medical Electrical Equipment Part 1-6: General . requirements for safety- Collateral standard: Usability o Intertek Project: 100825075BOX-003.
- . 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, 100933162BOX-017.
- . 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 5C2A: Intertek Report Number IEC60601-2-37 uSmart3200T 5C2A: 100825075BOX-006
- o Transducer Model 12L5A: Intertek Report Number IEC60601-2-37 uSmart3200T 12L5A: 100825075BOX-007
- o Transducer Model 4V2A: Intertek Report Number IEC60601-2-37 uSmart3200T 4V2A: 100825075BOX-005.
- . NEMA UD 3 Acoustic Output Display Terason uSmart3200T Ultrasound System User Guide (16-3301).
- Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- o Biocompatibility reports for all transducers.
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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 depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2013
TeraTech Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K131209
Trade/Device Name: Terason® uSmart3200T and BenQ UP200 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: May 15. 2013 Received: May 16, 2013
Dear Mr. Job:
This letter corrects our substantially equivalent letter of May 24, 2013.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Terason " uSmart3200T and BenQ UP200 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 12L5A |
|---|
| 5C2A |
| 4V2A |
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Page 2 - Mr. Mark Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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/CDRH/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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
If you have any questions regarding the content of this letter. please contact Robert Ochs. Ph.D. at (301) 796-6661.
Sincerely yours.
FDA
for
Janine M. Morris Director, Division of Radiological Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosures
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Indications for Use
510(k) Number (if known): K131209
Device Name: _Terason uSmart3200T and BenQ UP200 Ultrasound System
Indications for Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) is a The Teration ourporation Teracem intended for use by a qualified physician for evaluation by yenoral porpood of acconnelysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); exam types inolade. Total Aboundai, Reletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)________________________________________________________________________________________________________________________________________________________________________
Page 1 of 5
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510(k) Number (if known): K131209
| Indications For Use: Diagnostic ultrasound imaging system 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 | |||||||
| Fetalh | N | N | N | N | N | N | N | |
| Abdominalc: | N | N | N | N | N | N | N | |
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricc: | N | N | N | N | N | N | N |
| Small Organ (Thyroid,Breast, Testes, etc.)d: | N | N | N | N | N | N | N | |
| Neonatal Cephalicc: | N | N | N | N | N | N | N | |
| Adult Cephalicc: | N | N | N | N | N | N | N | |
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)c: | N | N | N | N | N | N | N | |
| Musculo-skel. (Superfic)c: | N | N | N | N | N | N | N | |
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vesselc: | N | N | N | N | N | N | N |
| Other (Specify) |
Device Name: _Terason uSmart3200T and BenQ UP200 Ultrasound System
ound imaging system or fluid flow analysis of the human body as follows:
Vessel N= new indication; P= previously cleared by FDA; E= added under Appendix E
No new Indication; P= previously cleared by I DA, L= addod Sharin =
ª Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
B+M; B+PWD; B+CD; B+DPD; B+PD.
C Harmonic Imaging (HI)
Includes ultrasound guidance for placement of needles, catheters.
· Abdominal, thoracic and peripheral vessel.
· Abdominal, thoracic and penpheral vosso.
I Includes ultrasound guidance for placement of needles, cathers of follolo dovelopment
Includes ultrasound guidance for placement of nocerso, of fortility monitoring of form
Includes guidance of amniocentesis, infertility monitoring of follicle development.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
r a come
{7}------------------------------------------------
510(k) Number (if known): K131209
Device Name: _Terason uSmart3200T and BenQ UP200 - 5C2A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppa | Comb.Modesb | |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Abdominali: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Small Organ (Thyroid,Breast, Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| 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 | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Ne new noneation, i = provided on on one Doppler (DPD), and (non-directional) Power Doppier.
b +M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
9 Includes ultrasound guidance for placement of needles, catheters.
9 Abdominal, thoracic and peripheral vessel.
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
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 K112953
| Prescription Use | x |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
n a come
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510(k) Number (if known): K131209
Device Name: _ Terason uSmart3200T and BenQ UP200 - 12L5A Transducer
Indications For Use: Diagnostic ultrasound imaging system or fluid ilow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Otherc | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppa | Comb.Modesb | |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetalh | |||||||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricc: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Small Organ (Thyroid,Breast, Testes, etc.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Neonatal Cephalicc: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Adult Cephalicd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
1 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)
Includes ultrasound guidance for placement of needles, catheters.
· Abdominal, thoracic 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 K112953
| Prescription Use | x |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
{9}------------------------------------------------
510(k) Number (if known): K131209
Device Name: __ Terason uSmart3200T and BenQ UP200 - 4V2A Transducer
Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Otherc | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppa | Comb.Modesb | |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetalb | P1 | P1 | P1 | P1 | P1 | P1 | |
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricc: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Small Organ (Thyroid,Breast, Testes, etc.)d: | ||||||||
| Neonatal Cephalicc: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Adult Cephalicc: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)d: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1 | P1 | P1 | P1 | P1 | P1 | |
| Cardiac Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vesseld: | |||||||
| Vessel | Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
No now nonomic (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
Includes ultrasound guidance for placement of needles, catheters.
9 Abdominal, thoracic and peripheral vessel.
1 Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
® Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
AND/OR
" Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P : uses previously cleared under K1 12953
Prescription Use __x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
mint
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_K131209
§ 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.