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-Card.) Musculo-skel. (Convent.), Musculo-skel. (Superfic); Cardiac (Adult & Pediatric); Trans-esophageal (Cardiac) Peripheral Vascular.

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.

AI/ML Overview

The document provided is a 510(k) premarket notification for the Terason uSmart3200T Ultrasound System, detailing its substantial equivalence to predicate devices. It focuses on the safety and performance aspects of the device and its transducers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated manner for the entire device. Instead, it describes various tests and standards met. However, it does provide specific acoustic output limits and the measured values for different transducers.

Acceptance Criteria Category	Specific Criteria / Standard Met	Reported Device Performance (Worst Case for each Transducer)
Acoustic Output	NEMA UD 2-2004, NEMA UD 3-2004, IEC 60601-2-37
	Global Maximum ISPTA.3	- 12L5A: 597 mW/cm²
		- 4V2A: 603 mW/cm²
		- 5C2A: 660 mW/cm²
		- 8EC4A: 633 mW/cm²
		- 16HL7: 554 mW/cm²
		- 15L4: 563 mW/cm²
		- 8L2: 598 mW/cm²
		- 8V3A: 560 mW/cm²
		- 9MC3: 577 mW/cm²
		- 8TE3: 245 mW/cm²
		- PDOF: 506 mW/cm²
	TI (Thermal Index)	- 12L5A: 3.3
		- 4V2A: 5.6
		- 5C2A: 4.7
		- 8EC4A: 2.29
		- 16HL7: 1.22
		- 15L4: 5.8
		- 8L2: 2.8
		- 8V3A: 4.7
		- 9MC3: 2.8
		- 8TE3: 1.0
		- PDOF: 4.2
	MI (Mechanical Index)	- 12L5A: 1.8
		- 4V2A: 1.5
		- 5C2A: 0.7
		- 8EC4A: 1.8
		- 16HL7: 1.6
		- 15L4: 1.7
		- 8L2: 1.7
		- 8V3A: 1.7
		- 9MC3: 1.3
		- 8TE3: 1.3
		- PDOF: 0.1
B-Mode Accuracy	AIUM Quality Assurance Manual for Gray-Scale Ultrasound Scanners	Evaluated (details not specified)
Doppler Accuracy	AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices	Evaluated (details not specified)
Doppler Sensitivity	AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices	Evaluated (details not specified)
Electrical Safety	IEC60601-1	Compliance verified
EMC	IEC 60601-1-2, CISPR11 Class B	Compliance verified
Usability	IEC60601-1-6	Compliance verified
Biocompatibility	ISO 10993 Part 5 and Part 10	Biocompatibility reports fulfilled
Software	IEC 62304 (Software Life Cycle Process), IEC 62366 (Application for Usability)	Undergone Quality Assurance testing

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a specific test set of patient data. The studies performed are primarily non-clinical bench tests on the ultrasound system and its transducers.

Data Provenance: Not applicable as the documented tests are primarily for physical and technical performance and safety, not diagnostic accuracy on patient data. The document mentions acoustic tank evaluations for transducers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The reported tests are not clinical studies that require expert-established ground truth on patient cases. They are technical performance evaluations against engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set with patient data requiring expert consensus or adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. The document describes the system's technical and safety characteristics, not its comparative effectiveness in a clinical reading environment with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical imaging device, not a standalone algorithm. The "performance" discussed relates to the physical and technical capabilities of the ultrasound system and its transducers.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" for the tests performed is primarily based on technical standards and specifications (e.g., NEMA UD 2, NEMA UD 3, IEC 60601-2-37 for acoustic output; AIUM guidelines for B-Mode and Doppler accuracy/sensitivity; ISO 10993 for biocompatibility). For a diagnostic device, the "ground truth" is that it performs according to these established and recognized technical and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a hardware-based diagnostic imaging system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI model or training set described in this document.

Summary

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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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic	N	N	N		N	N	N
FetalImaging& 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,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:
	Small Organ (Thyroid, Breast,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)
PeripheralVessel	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

{6}------------------------------------------------

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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricd:
	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:
	Musculo-skel. (Superfic)d:
	Intra-luminal
	Other (Specify)
	Cardiac Adult				N
Cardiac	Cardiac Pediatric				N
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.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
FetalImaging& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,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)
PeripheralVessel	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

{8}------------------------------------------------

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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.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
FetalImaging& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
FetalImaging& 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,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)
PeripheralVessel		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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e	P1	P1	P1		P1	P1	P1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:
	Small Organ (Thyroid, Breast,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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,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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppaa	Comb.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
FetalImaging& Other	Pediatricd:	P1,2	P1,2	P1,2		P1,2	P1,2	P1,2
	Small Organ (Thyroid, Breast,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)
PeripheralVessel	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 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
- Confirmed transducer geometries and characteristic parameters o
- o Confirmed 9MC3, 8TE3, PDOF, 8L2, 8V3A and ophthalmic-12L5A and 15L4 acoustic tables and added 8EC4A acoustic tables
- o Added 9MC3, 8TE3, PDOF, 8L2, 8V3A to the table of allowed transducers
- o Added imaging presets for 9MC3, 8TE3, PDOF, 8L2, 8V3A. Added presets for the new 15L4 and 12L5A ophthalmic mode. Added presets for the Trans-esophageal (non-Cardiac and Cardiac) modes.

{18}------------------------------------------------

7. Table of Similarities and Differences Compared to the Predicate Devices

Terason uSmart3200T System and Transducers Comparison and Discussion New Transducers 9MC3, 8TE3, PDOF, 8L2, 8V3A, and for Ophthalmic Indication for Use 15L4 and 12L5A Previously cleared transducers (12L5A, 5C2A, 4V2A, 8EC4A, 16HL7 and 15L4) (K140524)

Subject Device Model Comparable Predicate Device Comparable Predicate Terason uSmart3200T Terason uSmart3200T Device K140524 Sonosite Maxx (This Submission) K071792 Intended Use Diagnostic Ultrasound Diagnostic Ultrasound Diagnostic Ultrasound imaging or fluid flow analysis imaging or fluid flow analysis imaging or fluid flow analysis of the human body of the human body of the human body Indication for Use Ophthalmic, Fetal, Fetal, Abdominal, Intra-Fetal, Abdominal, Intra-Abdominal, Intra-operative operative (Spec.), Pediatric, operative (Spec.), Intra-(Spec.), Pediatric, Small Organ Small Organ (Thyroid, Breast, operative (Neuro), (Thyroid, Breast, Testes, etc.), Laparoscopic, Pediatric, Testes, etc.), Neonatal Neonatal Cephalic, Adult Cephalic, Adult Cephalic, Small Organ (Thyroid, Breast, Cephalic, Trans-rectal, Trans-Trans-rectal, Trans-vaginal, Testes, etc.), Neonatal vaginal, Trans-esophageal Musculo-skel. (Convent.), Cephalic, Adult Cephalic, (non-Cardiac), Musculo-skel. Musculo-skel. (Superfic), Trans-rectal, Trans-vaginal, (Convent.), Musculo-skel. Cardiac Adult, Cardiac Musculo-skel. (Convent.), (Superfic), Cardiac Adult, Pediatric, Peripheral vessel Musculo-skel. (Superficial), Cardiac Pediatric, Trans-Cardiac Adult, Cardiac esophageal (Cardiac), Pediatric, Trans-esophageal Peripheral vessel (Cardiac), Peripheral vessel Transducer Types Linear Array Linear Array Linear Array Curved Array Curved Array Curved Array Phased Array Phased Array Phased Array Endocavity — curved array Endocavity - curved array Endocavity - curved array Hockey Stick - Linear Hockey Stick - Linear Trans-esophageal Trans-esophageal PDOF Acoustic Output and FDA Display Features for High Display Features for High Display Features for High Limits Outputs Outputs Outputs Global Maximum ISPTA.3: 652.9 mW/cm² (4V2A) ISPTA.3: 652.9 mW/cm2 (4V2A) N/A Outputs/Worst Case Setting TI Type: TIC (15L4) TI Type: TIC (15L4) TI Value: 5.8 (15L4) TI Value: 5.8 (15L4) MI: 1.78 (8EC4A) MI: 1.78 (8EC4A) IPA.3@MI Max: 827 W/cm² lpA.3@MI Max: 827 W/cm² (15L4) (15L4) Modes of Operation B-Mode Grayscale Imaging B-Mode Grayscale Imaging B-Mode Grayscale Imaging Tissue Harmonic Imaging Tissue Harmonic Imaging Tissue Harmonic Imaging M-Mode (motion) M-Mode (motion) M-Mode (motion) Anatomical M-Mode Anatomical M-Mode Anatomical M-Mode Color M-Mode Color M-Mode Color M-Mode Color Power Doppler Color Power Doppler Color Power Doppler

Terason uSmart3200T Tablet Computer

{19}------------------------------------------------

	Velocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing	Velocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing	Velocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) Doppler
PW Doppler	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF	Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF
Transducer Frequency	2.0 - 15.0 MHz	2.0 - 15.0 MHz	2.0 - 15.0 MHz (est.)
#Transmit Channels	128 Channels	128 Channels	128 Channels
# Receive Channels	128 Channels	128 Channels	128 Channels
Acoustic OutputMeasurement Standard	NEMA UD 2-2004NEMA UD 3-2004	NEMA UD 2-2004NEMA UD 3-2004	NEMA UD 2-2004NEMA UD 3-2004
DICOM	DICOM 3.0 StructuredReporting, Worklist - ImageViewer	DICOM 3.0 StructuredReporting, Worklist - ImageViewer	DICOM supported
Product Safety Certification	IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37	IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37	IEC60601-1IEC60601-1-2IEC60601-1-4IEC60601-2-37
EMC	IEC60601-1-2CISPR11 Class B	IEC60601-1-2CISPR11 Class B	IEC60601-1-2CISPR11 Class B
SystemCharacteristics	uSmart3200T:tablet computerweighs 4.9 lbs (2.21 Kg)11.5" backlit touch screen.Tablet dimensions (8.82"(H) x12.64"(W) x 1.25"(D)).A Lithium-Polymer battery(integrated into the tablet)provides 2 hours ofcontinuous ultrasoundscanningDocking station (for charging)that uses a medical-gradepower supplyData transferred to the tabletcomputer over a FireWire(aka IEEE 1394)	uSmart3200T:tablet computerweighs 4.9 lbs (2.21 Kg)11.5" backlit touch screen.Tablet dimensions (8.82"(H) x12.64"(W) x 1.25"(D)).A Lithium-Polymer battery(integrated into the tablet)provides 2 hours ofcontinuous ultrasoundscanningDocking station (for charging)that uses a medical-gradepower supplyData transferred to the tabletcomputer over a FireWire(aka IEEE 1394)	Sonosite Maxx:Information available on thecorporate web site:http://www.sonosite.com.

Five transducers have been added to the Terason uSmart3200T in this submission: 9MC3, 8TE3, PDOF, 8L2 and 8V3A. The new indications for use (IFU) that are included in this submission are for Ophthalmic use with the 12L5A and 15L4 transducer, and Trans-esophageal use with the 8TE3.

{20}------------------------------------------------

SUMMARY OF NEW AND ASSOCIATED PREDICATE TRANSDUCERS

New Subject Transducer	Comparable Predicate Transducer	Predicate Approvals and Systems
Terason 9MC3 micro-convex	Terason 8MC3 micro-convex	K112953 (Terason t3000)
Terason 8TE3 trans-esophageal	Philips S7-3t trans-esophageal	K132304 (Philips EPIQ)K070792 (Philips iE33)
Terason PDOF	Aloka UST-T109 PDOF	K110482 (Aloka ProSound C3)
Terason 8L2 linear	Terason 8L2 linear	K140773 (Terason uSmart3300)
Terason 8V3A phased	Terason 8V3A phased	K140773 (Terason uSmart3300)

TRANSDUCER PERFORMANCE SUMMARY

Transducer	Indications	Mode	Global maximum output	510(K)control number
12L5A	Ophthalmic, Abdominal, Pediatric,Small Organ (breast, testes, thyroid),Neonatal and Adult Cephalic,Musculo-sketetal (Conventional andSuperficial), and Peripheral Vascular	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 597(mW/cm²)TI = 3.3MI = 1.8	K140524 changesto add ophthalmicuse
4V2A	Fetal, Abdominal, Pediatric, Neonataland Adult Cephalic, Cardiac (adultand pediatric)	B, M,PWD,Color Doppler,CWD,Combined	$I_{STPA.3}$ = 603 (mW/cm²)TI = 5.6MI = 1.5	K140524
5C2A	Fetal, Abdominal, Pediatric, Musculo-sketetal (Conventional andSuperficial), Cardiac (adult andpediatric) and Peripheral Vascular	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 660 (mW/cm²)TI = 4.7MI = 0.7	K140524
8EC4A	Fetal, Trans-rectal, Trans-vaginal	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 633(mW/cm²)TI = 2.29MI = 1.8	K140524
16HL7	Intra-Operative (abdominal, organsand vascular), Small Organ (Thyroid,Breast, Testes); Musculo-skeletal(Conventional and Superficial);Peripheral Vascular.	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 554(mW/cm²)TI = 1.22MI = 1.6	K140524
15L4	Ophthalmic, Abdominal, Pediatric,Small Organ (Thyroid, Breast,Testes); Musculo-skeletal(Conventional and Superficial);Peripheral Vascular.	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 563(mW/cm²)TI = 5.8MI = 1.7	K140524 changesto add ophthalmicuse
8L2	Abdominal, Pediatric, Musculo-skeletal, Peripheral Vascular	B, M,PWD,Color Doppler,Combined	$I_{STPA.3}$ = 598(mW/cm²)TI = 2.8MI = 1.7	NEW
8V3A	Fetal, Abdominal, Pediatric, Cephalic,and Cardiac	B, M,PWD,Color Doppler,CWD,Combined	$I_{STPA.3}$ = 560(mW/cm²)TI = 4.7MI = 1.7	NEW
9MC3	fetal, pediatric, small organs, cephalic	B, M,	$I_{STPA.3}$ = 577(mW/cm²)	NEW

{21}------------------------------------------------

	(neonatal and adult), cardiac andperipheral vessels	PWD,Color Doppler,CWD,Combined	TI = 2.8MI = 1.3
8TE3	Trans-esophageal (non-cardiac andcardiac)	B, M,PWD,Color Doppler,CWD,Combined	$I_{STPA.3} = 245(mW/cm^2)$TI = 1.0MI = 1.3	NEW
PDOF	Cardiac	CWD	$I_{STPA.3} = 506(mW/cm^2)$TI = 4.2MI = 0.1	NEW

9MC3 Transducer

Key Features	Subject Device ModelTerason 9MC3 Transducer	Comparable PredicateDeviceTerason 8MC3 Transducer	Same or Different
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K112953	n/a
Indications for Use	The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3200T) to image fetal,pediatric, small organs,cephalic (neonatal andadult), cardiac and peripheralvessels.	The transducer is intendedto be used with aconventional ultrasoundsystem (Terason t3000) toimage fetal, pediatric, smallorgans, cephalic (neonataland adult), cardiac andperipheral vessels.	Same. The proposedtransducer and the predicatetransducer have the identicalclaim of imaging similarregions in the human body.
Acoustic Array Technology:	Piezoelectric elements	Piezoelectric elements	Same.Regarding Safety: Same.Effectiveness: Both arraysallow focused transmissionand reception of ultrasoundenergy to enhance imagequality within the region ofinterest.
Acoustic Array Style:	Micro Curved Array	Micro Curved Array	allow focused transmissionand reception of ultrasoundenergy to enhance imagequality within the region ofinterest.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	806.50.321mm X 6.0mm30mm	1285.00.25mm X 8.0mm40mm	Different: Element count,center frequency, elementsize and elevation focus.Acoustic characteristics havemet safety guidelines ofIEC60601-2-37. Safety andeffectiveness unchangedfrom predicate.

{22}------------------------------------------------

Acoustic Array	The transducer imagingperformance has beenevaluated in an acoustictank.	The transducer performancehas been evaluated in theprevious 510(k) filing(K112953).	Same: The 9MC3 uses a sameacoustic array materials asthe predicate device andtherefore has same acousticcharacteristics. To ensureproper safety guidelines aremet, acoustic testing wasperformed per the IEC60601-2-37 standard.
Patient Contact Material	Silicone ABS	Silicone ABS	Same: Biocompatible.

The 9MC3 uses a same acoustic array materials as the predicate (8MC3) device and therefore has same acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The transducer has been added to the uSmart3200T Ultrasound system.

The 9MC3 consists of same patient contact material as the predicate device. To ensure proper safety guidelines are met, biocompatibility tests were run on the patient contact materials.

Transducer 8TE3

Key Features	Subject Device Model	Comparable PredicateDevice	Same or Different
	Terason(Oldelft) 8TE3Transducer	Philips(Oldelft) S7-3t
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXXX	K132304 (EPIQ)K070792 (iE33)	n/a
Indications for Use	The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3200T) for trans-esophageal (non-cardiac andcardiac) imaging.	The transducer is intended tobe used with a conventionalultrasound system (PhilipsEPIQ) for trans-esophageal(non-cardiac and cardiac)imaging.	Same. The proposedtransducer and thepredicate transducer havethe identical claim ofimaging similar regions inthe human body.
Acoustic Array Technology	Piezoelectric elements	Piezoelectric elements	Same
Transducer Style	TE (Trans-esophageal)	TE (Trans-esophageal)	Same.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...	645.0 MHz0.16mm X 9.6mm50mm	645.0 MHz0.16mm X 9.6mm50mm	Same.

{23}------------------------------------------------

Elevation focus...
Array Rotation:Insertion length:Diameter:Bending capabilities:	180 degrees41.0 mm (inflexible)11.0 mm≥ 120° upwards (clockwiserotation of knob)≥ 90° backwards (counter-clockwise rotation of knob)≥ 45° left≥ 45° right	180 degrees41.0 mm (inflexible)11.0 mm≥ 120° upwards (clockwiserotation of knob)≥ 90° backwards (counter-clockwise rotation of knob)≥ 45° left≥ 45° right
Acoustic Output and DeviceSettings	The transducer performancehas been evaluated in anacoustic tank.	The transducer performancehas been evaluated in theprevious 510(k) filings(K132304, K070792).	Same.
Patient Contact Material	Silicone	Silicone	Same. The 8TE3 and thepredicate S7-3t transducersare both manufactured byOldelft and consist ofidentical patient contactmaterials.

There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3200T Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 8TE3 transducer is substantially equivalent to the predicate TE transducer with respect to safety and effectiveness.

PDOF Transducer

Key Features	Subject Device Model	Comparable Predicate Device	Same or Different
DeviceClassification	ITX	ITX	Same
510(k) Number	KXXXXXX	K110482	n/a
	Terason uSmart3200T PDOFTransducer	Aloka(Terason) ProSound C3UST-T109 PDOF Transducer

{24}------------------------------------------------

Indications forUse	The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3200T) for Cardiaccontinuous-wave Doppler(CWD) (adult and pediatric).	The transducer is intended to beused with a conventionalultrasound system(Aloka/Terason ProSound C3) forCardiac continuous-wave Doppler(CWD) (adult and pediatric).	Same. The proposed transducerand the predicate transducer havethe identical claim of imagingsimilar regions in the human body.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.Regarding Safety: Both arraysallow focused transmission andreception of ultrasound energy toenhance image quality within theregion of interest.
Acoustic ArrayStyle:	Pencil Transducer	Pencil Transducer	Same.
Acoustic ArrayCharacteristics:Element count...CenterfrequencyElement size(diameter)...Elevation focus...	22.0MHz13.8mm55mm	22.0MHz13.8mm55mm	Same.
Acoustic Array	The transducer CWDperformance has beenevaluated in an acoustic tank.	The transducer CWDperformance has been evaluatedin the previous 510(k) filing(K110482).	Same. As the predicate device andtherefore has same acousticcharacteristics. To ensure propersafety guidelines are met, acoustictesting was performed per theIEC60601-2-37 standard.
Patient ContactMaterial	Epoxy Noryl	Epoxy Noryl	Same. The PDOF transducerconsists of identical patientcontact materials as the predicatedevice.

There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3200T Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason PDOF transducer is substantially equivalent to the predicate PDOF transducer with respect to safety and effectiveness.

8L2 Transducer

Key Features	Subject Device Model	Comparable Predicate	Same or Different
	Terason 8L2 Transducer	Device
		Terason 8L2 Transducer

{25}------------------------------------------------

Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K140773	n/a
Indications for Use	The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3200T) to imageAbdominal, Pediatric,Musculo-skeletal, PeripheralVascular.	The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3300) to imageAbdominal, Pediatric,Musculo-skeletal, PeripheralVascular.	Same.
Acoustic Array Technology:	Piezoelectric elements	Piezoelectric elements	Same.Same. Regarding Safety: Thisarray allows focusedtransmission and reception ofultrasound energy to enhanceimage quality within theregion of interest.
Acoustic Array Style:	Linear Array	Linear Array	Same.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	1285.0 MHz0.3mm X 6.0mm40mm	128 elements5.0 MHz0.3mm X 6.0mm40mm	Same.
Acoustic Array	The transducer imagingperformance has beenevaluated in an acoustictank.	The transducer performancehas been evaluated in theprevious 510(k) filing(K140773).	Same. As the predicatedevice and therefore has thesame acoustic characteristics.To ensure proper safetyguidelines are met, acoustictesting was performed perthe IEC60601-2-37 standard.
Patient Contact Material	SIM R100	SIM R100	Same.

The uSmart3200T uses a same 8L2 transducer as the predicate uSmart3300 device and therefore has identical acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The 8L2 transducer used with the uSmart3200T consists of the same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 8L2 transducer meets safety and effectiveness guidelines.

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8V3A Transducer

Key Features	Subject Device Model	Comparable Predicate	Same or Different
	Terason 8V3A Transducer	Device
		Terason 8V3A Transducer
Device Classification	ITX	ITX	Same

510(k) Number	K1XXXXXX	K140773	n/a

Indications for Use	The transducer is intended	The transducer is intended	Same.
	to be used with a	to be used with a
	conventional ultrasound	conventional ultrasound
	system (Terason	system (Terason
	uSmart3200T) to image	uSmart3300) to image Fetal,
	Fetal, Abdominal, Pediatric,	Abdominal, Pediatric,
	Cephalic, and Cardiac.	Cephalic, and Cardiac.
Acoustic Array Technology:	Piezoelectric elements	Piezoelectric elements	Same.
			Regarding Safety: This array
			allows focused transmission
Acoustic Array Style:	Phased Array	Phased Array	and reception of ultrasound
			energy to enhance image
			quality within the region of
			interest.
Acoustic Array			Same.
Characteristics:
Element count	વેરિ	તેરૂ
Center frequency	4.7 MHz	4.7 MHz
Element size (pitch x	0.16mm X 8mm	0.16mm X 8mm
elevation)
Elevation focus	49mm	49mm
Acoustic Array	The transducer imaging	The transducer performance	Same. As the predicate
	performance has been	has been evaluated in the	device and therefore has
	evaluated in an acoustic	previous 510(k) filing	identical acoustic
	tank.	(K140773).	characteristics. To ensure
			proper safety guidelines are
			met, acoustic testing was
			performed per the IEC60601-
			2-37 standard.
Patient Contact Material	Silicone Valox	Silicone Valox	Same.

The uSmart3200T uses a same 8V3A transducer as the predicate uSmart3300 device and therefore has identical acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard. The 8V3A transducer used with the uSmart3200T consists of the same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 8V3A transducer meets safety and effectiveness guidelines.

{27}------------------------------------------------

15L4 Transducer

Key Features	Subject Device Model	Comparable Predicate	Same or Different
	Terason 15L4 Transducer	Device
		Sonosite Edge L25x/13-6
		Transducer
510(k) Number	K1XXXXXX	K082098	n/a
Classification	ITX	ITX	Same
Indications for Use	The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3200T) to imageophthalmic, abdomen, smallparts, musculo-skel,peripheral vascular regions.Ophthalmic is the new IFU.	The transducer is intendedto be used with aconventional ultrasoundsystem (Sonosite Edge) toimage ophthalmic,abdomen, pediatric, smallparts, musculo-skel andperipheral vascular regions.	Different: The proposedtransducer and the predicatetransducer have the claim ofimaging similar regions in thehuman body. Ophthalmic isthe new Indication for Use.
Acoustic Array Technology:	Piezoelectric elements	Piezoelectric elements	Same: Safety requirements ofIEC60601 are equally met.Effectiveness: Both arrays
Acoustic Array Style:	Linear Array	Linear Array
			allow focused transmissionand reception of ultrasoundenergy to enhance imagequality within the region ofinterest.
Acoustic Array Characteristics:Element countCenter frequencyElement size (pitch xelevation)Elevation focus	128 elements7.5 MHz0.3mm X 4.0mm20mm	128 elements9.5 MHz (est)0.195mm X 3.0mm (est)18mm (est)	Same: element count.Acoustic characteristics havemet safety guidelines ofIEC60601-2-37.
Acoustic Output and DeviceSettings	The transducer performancehas been evaluated in anacoustic tank.	The transducerperformance has beenevaluated in the 510(k)filing (K082098).	Different; acoustic outputsafety guidelines. Safety isnot compromised.Effectiveness equal.

{28}------------------------------------------------

Patient Contact Material	Silicone ABS	Silicone ABS	Same. The 15L4 transducerconsists of same patientcontact materials as thepredicate device. The safetyof each device with respect tobiocompatibility is equivalent.
--------------------------	--------------	--------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The 1514 uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard. The 15L4 transducer consists of same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4 transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 15L4 transducer can be safely used for ophthalmological use.

Key Features	Subject Device Model	Comparable Predicate Device	Same or Different
	Terason 12L5A Transducer	Sonosite Edge L25x/13-6Transducer
DeviceClassification	ITX	ITX	Same
510(k) Number	KXXXXX	K082098	n/a
Indications forUse	The transducer is intended to beused with a conventionalultrasound system (TerasonuSmart3200T) to imageophthalmic, fetal, abdominal,pediatric, small organ, cephalic,musculo-skel, cardiac andperipheral vessel.Ophthalmic is the new IFU.	The transducer is intended tobe used with a conventionalultrasound system (SonositeEdge) to image ophthalmic,abdomen, pediatric, small parts,musculo-skel and peripheralvascular regions.	Same. The proposed transducerand the predicate transducerhave the identical claim ofimaging similar regions in thehuman body.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.Regarding Safety: Both arraysallow focused transmission and
Acoustic ArrayStyle:	Linear Array	Linear Array	reception of ultrasound energyto enhance image quality withinthe region of interest.
Acoustic ArrayCharacteristics:			Same in elevation Safety andeffectiveness unchanged frompredicate
Element count...	128	128
Centerfrequency...	7.5MHz	9.5MHz (est)
Element size(pitch xelevation)...	0.3mm X 4.0mm	0.195mm X 3.0mm (est)
	19mm	18mm (est)

12L5A Transducer

{29}------------------------------------------------

Elevation focus...
Acoustic Array	The transducer imagingperformance has been evaluated inan acoustic tank.	The transducer performancehas been evaluated in theprevious 510(k) filing(K082098).	Same. As the predicate deviceand therefore has same acousticcharacteristics. To ensure propersafety guidelines are met,acoustic testing was performedper the IEC60601-2-37 standard.
Patient ContactMaterial	Silicone ABS	Silicone ABS	Same. The 12L5A transducerconsists of same patient contactmaterials as the predicatedevice.

The 12L5A uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard. The 12L5A transducer consists of same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 12L5A transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 12L5A transducer can be safely used for ophthalmological use.

Previously filed transducers:

The following transducers are identical to those previously cleared under FDA 510(k) K140524, March 21, 2014 for the Terason uSmart3200T:

. 4V2
. 5C2A
8EC4A
. 12L5A (not including Ophthalmic use)
. 15L4 (not include Ophthalmic use)
. 16HL7.

Conclusion:

The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3200T and predicate devices both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3200T and predicate devices both meet FDA requirements for track 3 devices, indications for use, biocompatibility similarities, and are manufactured using FDA GMPs and ISO-13485 quality systems. Teratech Corporation believes that the uSmart3200T ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate devices.

{30}------------------------------------------------

8. Summary of Bench Tests and Non-Clinical Tests

The Terason uSmart3200T system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

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
- Oldelft EMC Technical Report 2011-002
- EMC Emissions Evaluation of Terason uSmart3200T with 3 port o MUX, Intertek 100933162BOX-017
- O EMC Emissions Evaluation of Terason uSmart3200T with 8L2, 8V3A, PDOF, 9MC3 Transducers, Intertek 101753691BOX-001
- EMC Emissions Evaluation of uSmart3200T Cart with 8TE3 o Transducer, Intertek 101885790BOX-002
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 4V2A Transducer
- 5C2A Transducer o
- 8EC4A Transducer o
- 16HL7 Transducer o
- 8TE3 Transducer O
- 8L2Transducer O
- 8V3ATransducer O
- 9MC3 Transducer O
- 12L5A Transducer O
- 15L4 Transducer O
- PDOF Transducer o
Biocompatibility Tests, ISO 10993 Part 5 and Part 10
- Biocompatibility reports for the new transducers
AAMI TIR No. 12:210, Designing, Testing and Labeling Reusable . Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

{31}------------------------------------------------

The ultrasound system acoustic output was test in accordance with the following:

IEC 61157, Ed. 2 2007-2008, Standard Means for the Reporting of the ● Acoustic Output of Medical Diagnostic Ultrasonic Equipment
NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic ● Ultrasound Equipment, Revision 3
. NEMA UD 3, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2.

The ultrasound system B-Mode Accuracy, Doppler Accuracy and Doppler Sensitivity for each Terason transducer have been evaluated according to the following:

. American Institute of Ultrasound in Medicine (AIUM) Quality Assurance Manual for Gray-Scale Ultrasound Scanners
AIUM Methods for Measuring Performance of Pulse-Echo Ultrasound . Imaging Equipment, Part II: Digital Methods
. AIUM Performance Criteria and Measurements for Doppler Ultrasound Devices.

The Terason uSmart3200T Software has undergone Quality Assurance testing consistent with IEC 62304, Software Life Cycle Process, and IEC 62366, Application for Usability.

9. Summary of Conclusions

The predicate system (uSmart3200T, K140524) and associated predicate transducers (Terason 8MC3, K112953; Philips S7-3t, K132304 and K070792; Aloka UST-T109 PDOF, K110482; Terason 8L2 and 8V3A, K140773) are legally marketed. The new system and associated transducers have the same intended use as the predicate system and devices. The Terason uSmart3200T and associated transducers represent a new implementation of familiar technology and therefore possess new technological characteristics that are validated in this filing. The performance data used to validate the Terason uSmart3200T and 9MC3, 8TE3, PDOF, 8L2 and 8V3A transducers includes the following:

Acoustic output testing .

{32}------------------------------------------------

B-Mode accuracy, and Doppler accuracy and sensitivity .
. General requirements for safety testing
Electromagnetic compatibility testing .
. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment testing
Biocompatibility testing of patient contact materials .
Burn-in testing .
Software performance and regression testing. .

Regulation Number and Section

§ 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.