Terason uSmart3200T Ultrasound System
Device Facts
| Record ID | K150533 |
|---|---|
| Device Name | Terason uSmart3200T Ultrasound System |
| Applicant | Teratech Corp. |
| Product Code | IYN · Radiology |
| Decision Date | May 9, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
Device Story
Portable tablet-style ultrasound system; acquires/displays real-time high-resolution ultrasound data. Proprietary ultrasound engine controls acoustic output/processes return echoes; data transferred via FireWire (IEEE 1394) to tablet for image generation. Used in clinical settings by physicians. Tablet features 11.5" touchscreen; battery-powered; docking station for charging. System supports multiple transducers (linear, curved, phased, pencil, trans-esophageal). Output provides visual diagnostic data; assists in clinical decision-making for various anatomical evaluations and interventional guidance. Benefits include portability and real-time diagnostic imaging.
Clinical Evidence
Bench testing only. No clinical data. Performance validated via acoustic output testing (IEC 61157, NEMA UD 2/3), B-Mode/Doppler accuracy and sensitivity testing (AIUM standards), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993).
Technological Characteristics
Portable tablet (4.9 lbs, 11.5" touchscreen) running Windows 7. Proprietary ultrasound engine inside tablet; FireWire connectivity. Transducers: Piezoelectric arrays (linear, curved, phased, pencil, TE). Materials: Silicone, ABS, Epoxy Noryl, Valox. Standards: IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3. Software: Rule-based processing of acoustic echoes.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in patients requiring Ophthalmic, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal, Musculo-skeletal, Cardiac, and Peripheral Vascular exams. Includes guidance for needle/catheter placement, cryosurgery, brachytherapy, and infertility monitoring.
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 uSmart3200T Ultrasound System (K140524)
- Terason T3000 8MC3 Transducer (K112953)
- Philips (Oldelft) S7-3t TE Transducer Probe (K132304)
- Aloka/Terason Ultrasound System with PDOF Transducer (K110482)
- Terason uSmart3300 8L2 and 8V3A Transducers (K140773)
- Sonosite Edge System L25x/13-6 Transducer (K082098)
Related Devices
- K193510 — Terason uSmart3200T Ultrasound System · Teratech Corporation · Jan 28, 2020
- K201633 — Terason uSmart 3200T Plus Ultrasound System · Teratech Corporation · Jul 2, 2020
- K140834 — TERASON USMART3400 ULTRASOUND SYSTEM · Teratech Corp. · Apr 25, 2014
- K131209 — TERASON USMART3200T ULTRASOUND SYSTEM · Teratech Corp. · May 24, 2013
- K250791 — ASUS Ultrasound Imaging System (LU800 series) · Asustek Computer, Inc. · Dec 4, 2025
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2015
Teratech Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K150533
Trade/Device Name: Terason uSmart3200T Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 22, 2015 Received: April 23, 2015
Dear Mr. Job:
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 Ultrasound System, as described in your premarket notification:
### Transducer Model Number
| 9MC3 | 8TE3 | PDOF | 15L4 | 12L5A |
|------|------|-------|-------|-------|
| 8L2 | 8V3A | 16HL7 | 8EC4A | 5C2A |
| 4V2A | | | | |
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.
{1}------------------------------------------------
Page 2-Mr. Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See P R A Statement on last page.
| 510(k) Number (if known) |
|--------------------------|
| K150533 |
### Device Name
Terason uSmart3200T Ultrasound System
Indications for Use (Describe)
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: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
O Over The Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (C D R H) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 13
P S C Publishing Services (301) 443-6740 EF
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510(k) Number (if known):
| | Device Name: Terason uSmart3200T Ultrasound System | |
|--|-------------------------------------------------------|--|
|--|-------------------------------------------------------|--|
Indications For Use: Diagnostic ultrasound imaging system 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 | N | N | N | | N | N | N |
| Fetal<br>Imaging<br>& Other | Fetalh | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Spec.)d,e | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Neonatal Cephalicd: | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Adult Cephalicd: | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Trans-rectalf: | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Trans-vaginalg: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | N | N | N | N | N |
| | 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 | P1 | P1 | P1 | P1 | P1 | P1 | P1 |
| | Cardiac Pediatric | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1 | P1 | P1 | N | P1 | P1 | P1 |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic and peripheral vessel.
f Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
AND/OR
Additional Comments: P1: uses previously cleared under K140773
Prescription Use _ ______________________________________________________________________________________________________________________________________________________________________________
(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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)__
Page 2 of 13
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510(k) Number (if known): _________
Device Name: Terason uSmart3200T - 9MC3 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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<br>Imaging<br>& Other | Fetalh | N | N | N | N | N | N | N |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | N | N | N | N | N | N | N |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | N | N | N | N | N | N | N |
| | Neonatal Cephalicd: | N | N | N | N | N | N | N |
| | Adult Cephalicd: | N | N | N | N | N | N | N |
| | 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 | N | N | N | N | N | N | |
| | Cardiac Pediatric | N | N | N | N | N | N | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | N | N | N | N | N | N | N |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic and peripheral vessel.
1 Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
In 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)_
Page 3 of 13
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### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 8TE3 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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<br>Imaging<br>& Other | Fetalh | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | N | N | N | N | N |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b 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)_
Page 4 of 13
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### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - PDOF Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | | | | | | | |
| | Fetalh | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | N | | | |
| Cardiac | Cardiac Pediatric | | | | N | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b 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)_
Page 5 of 13
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### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 15L4 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | N | N | N | | N | N | N |
| | Fetalh | | | | | | | |
| | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
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)_
Page 6 of 13
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### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 12L5A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | N | N | N | N | N | N | N |
| | Fetalh | | | | | | | |
| | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
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)_
Page 7 of 13
{9}------------------------------------------------
### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 8L2 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 |
| Fetal<br>Imaging<br>& Other | Ophthalmic | Ophthalmic | | | | | | | |
| | | Fetalh | | | | | | | |
| | | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | | Intra-operative (Spec.)d,e | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | | Neonatal Cephalicd: | | | | | | | |
| | | Adult Cephalicd: | | | | | | | |
| | | 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) | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
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)_
Page 8 of 13
{10}------------------------------------------------
### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 8V3A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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<br>Imaging<br>& Other | Fetalh | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Abdominald: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | 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: | | | | | | | |
| | 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<br>Vessel | Peripheral vesseld: | | | | | | | |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
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)_
Page 9 of 13
{11}------------------------------------------------
### 510(k) Number (if known):
#### Device Name: Terason uSmart3200T - 16HL7 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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<br>Imaging<br>& Other | Fetalh | | | | | | | |
| | Abdominald: | | | | | | | |
| | Intra-operative (Spec.)d,e | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | | | | | | | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | 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) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K110020
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)_
Page 10 of 13
{12}------------------------------------------------
### 510(k) Number (if known):
#### Device Name: Terason uSmart3200T - 8EC4A Transducer
Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|-------------------------------|-------------------|----|-----|-----|-------|--------|-------|
| General | Specific | B | M | PWD | CWD | Color | Comb. | Other |
| (Track I Only) | (Tracks I & III) | | | | | Doppa | Modesb | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetalª | p1 | p1 | P1 | | P1 | P1 | P1 |
| | Abdominal®: | | | | | | | |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal | Pediatric®: | | | | | | | |
| lmaqing | Small Organ (Thyroid, Breast, | | | | | | | |
| & Other | Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalica: | | | | | | | |
| | Adult Cephalica: | | | | | | | |
| | Trans-rectalf: | P1 | P1 | P1 | | P1 | P1 | P1 |
| | Trans-vaginal®: | p1 | P1 | P1 | | P1 | P1 | P1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vesselª: | | | | | | | |
| 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b 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)_
Page 11 of 13
{13}------------------------------------------------
### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 5C2A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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<br>Imaging<br>& Other | Fetalh | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Abdominald: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | P2 | P2 | P2 | | P2 | P2 | P2 |
| | Musculo-skel. (Convent.)d: | P2 | P2 | P2 | | P2 | P2 | P2 |
| | Musculo-skel. (Superfic)d: | P2 | P2 | P2 | | P2 | P2 | P2 |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P2 | P2 | P2 | | P2 | P2 | P2 |
| | Cardiac Pediatric | P2 | P2 | P2 | | P2 | P2 | P2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
AND/OR
Additional Comments: P1: uses previously cleared under K112953
P2: uses previously cleared under K131209
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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)_
Page 12 of 13
{14}------------------------------------------------
### 510(k) Number (if known):
### Device Name: Terason uSmart3200T - 4V2A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | | | | | | | |
| | Fetalh | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Abdominald: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Adult Cephalicd: | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | 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 | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Cardiac Pediatric | P1,2 | P1,2 | P1,2 | | P1,2 | P1,2 | P1,2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | 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 B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
AND/OR
Additional Comments: P1: uses previously cleared under K112953
P2: uses previously cleared under K131209
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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)_
Page 13 of 13
{15}------------------------------------------------
### 510(k) Summary or Statement
### Teratech Corporation
### Terason uSmart3200T Ultrasound System
### 1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Ben Chiampa Director of Quality Assurance Telephone: 781-270-4143
Date Prepared: March 31, 2015
### 2. Device Name
Proprietary Name: Terason uSmart3200T Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer
Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
### 3. Predicate Device
Terason uSmart3200T Ultrasound System (K140524)
Supporting Predicate Devices: Terason™ T3000 8MC3 Transducer (K112953) Philips (Oldelft) S7-3t TE Transducer Probe (K132304) Aloka/Terason Ultrasound System with PDOF Transducer (K110482) Terason uSmart3300 8L2 and 8V3A Transducers (K140773) Sonosite Edge System L25x/13-6 Transducer (K082098)
{16}------------------------------------------------
### 4. 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: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (Cardiac) Peripheral Vascular.
## 5. Device Description
The Terason uSmart3200T ultrasound system is a portable tablet-style, fullfeature, general purpose diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Ultrasound System is equivalent to the previously cleared versions of the uSmart3200T Ultrasound Systems. The modification includes the addition of 5 transducers (9MC3, 8TE3, PDOF, 8L2, 8V3A), the Trans-esophageal (non-Cardiac and Cardiac) IFUs and the Ophthalmic IFU associated with the 12L5A and 15L4 transducers with no change to the tablet-style computer form factor.
The Terason™ uSmart3200T ultrasound system was the previously cleared on the dates of May 28, 2013 and May 21, 2014 as described in the 510(k) submission (K140524). 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 computer over a FireWire (aka IEEE 1394) connection for further processing and qeneration/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 devices, the uSmart3200T and uSmart3300. Optional accessories include a cart and printer.
{17}------------------------------------------------
## 6. Technology Characteristics
The design and construction of the Terason uSmart3200T is the same as the Terason uSmart3200T Ultrasound system which was cleared in May 2013 and May 2014. This system utilizes a portable computer running Windows 7 to run the ultrasound application and a custom hardware designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is inside the tablet.
The uSmart3200T system contains the same ultrasound engine as the predicate device Terason uSmart3200T ultrasound system for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet computer over a FireWire connection for further processing, and generation and display of the ultrasound image
The differences between the Terason uSmart3200T and the previous Terason uSmart3200T Ultrasound System (the predicate device) include the following:
- . Five transducers have been added to the system along. The new Ophthalmic Indication for Use is associated with the 12L5A and 15L4 transducers. The Trans-esophageal (non-Cardiac and Cardiac) Indications for Use are also new. The software has been modified to control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
- Added support for 9MC3, 8TE3, PDOF, 8L2, 8V3A transducers .
- o Confirmed transducer id numbers and names
-…
