The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (abdominal, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

Device Description

The Terason uSmart3200T ultrasound system is a portable tablet style full feature, general purpose, and 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 version of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers (15L4, 16HL7, and 8EC4A) with the no change to tablet style computer form factor.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date of May 28, 2013 as described in the 510(k) submission (K131209). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. This data are then transferred to the tablet computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11.5" backlit touch screen. The tablet dimensions (8.82"(H) x 12.64"(W) x 1.25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medicalgrade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the uSmart3200T. Optional accessories include a cart and printer.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Terason uSmart3200T and BenQ UP200 Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested in terms of acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert ground truth establishment, or training set details.

The submission primarily lists the device's technical specifications and how they compare to predicate devices. The "Non Clinical Tests" section refers to compliance with various electrical safety, usability, and acoustic output standards, which serve as the "acceptance criteria" for regulatory clearance in this context. However, these are performance standards, not clinical performance metrics.

Here's a summary of the available information based on your request, highlighting what is not present in this type of regulatory document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally compliance with international and national standards for medical devices, particularly regarding safety and technological characteristics. The "reported device performance" is demonstrated through this compliance and the assertion of substantial equivalence to predicate devices which have already met such criteria.

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance)
IEC 60601-1: General Requirements for Safety	Compliance demonstrated via Intertek Test Record Number 100825075BOX-001
IEC 62366 & IEC60601-1-6: Usability engineering	Compliance demonstrated via Intertek Projects 100825075BOX-004A & 100825075BOX-003A
IEC 60601-1-2: Electromagnetic Compatibility (EMC)	Compliance demonstrated via Test Record Number 100933162BOX-017 and Radiated Emissions Reports (101224397BOX-001, 101188849BOX-001a)
CISPR11 Class B: Radiated Emissions	Compliance demonstrated via Radiated Emissions Reports (101224397BOX-001, 101188849BOX-001a)
IEC 60601-2-37 / EN60601-2-37: Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment (for transducers)	Compliance demonstrated via Intertek Reports for each transducer (100404852BOX-002, 100404852BOX-004, 100404852BOX-003)
NEMA UD 3: Acoustic Output Display	Compliance mentioned
Biocompatibility Tests (ISO 10993 Part 5 and Part 10)	Compliance demonstrated via biocompatibility reports for new transducers
AAMI TIR No. 12: Designing, Testing and Labeling Reusable Medical Devices	Compliance mentioned
GMPs & ISO-13485 quality systems	Compliance asserted
Track 3 devices, Indications for Use (for predicate devices)	Similar indications for use and technological characteristics to predicate devices (K131209, K112953, K110020)

2. Sample size used for the test set and the data provenance

This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The tests performed are non-clinical compliance tests against established safety and electrical standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not pertain to a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring 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 is a 510(k) submission for a diagnostic ultrasound system and transducers, which does not involve AI or comparative effectiveness studies with human readers.

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

Not applicable, as this device does not involve a standalone algorithm for performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical ground truth is established or used in this submission. The "ground truth" here is compliance with engineering and safety standards.

8. The sample size for the training set

Not applicable, as this document does not describe a machine learning model or training set.

9. How the ground truth for the training set was established

Not applicable, for the same reason as above.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence primarily by:

Listing the device's technical characteristics and comparing them directly to previously cleared predicate devices (Terason uSmart3200T (K131209), Terason™ t3000 (K112953), Terason™ T3200 (K110020)).
Highlighting that the modifications (addition of three transducers and software updates) do not alter the fundamental technological characteristics or intended use.
Providing evidence of compliance with a comprehensive set of non-clinical safety, electrical, usability, and acoustic output standards.

The "study" that proves the device meets the "acceptance criteria" here consists of these non-clinical tests and direct comparisons to predicate devices, rather than clinical performance studies with patient data. The regulatory body (FDA) reviews these submissions to ensure the new device is as safe and effective as existing legally marketed devices, without requiring new clinical efficacy data if substantial equivalence is adequately demonstrated.

Summary

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K140524
Page 1 of 15

510(k) Summary or Statement

Teratech Corporation

Terason uSmart3200T and BenQ UP200 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: February 18, 2014

2. Device Name

Terason uSmart3200 and BenQ UP200 Ultrasound System Proprietary Name: 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 (K131209) Terason™ t3000 Ultrasound System (K112953) Terason™ T3200 Ultrasound System (K110020)

4. Intended Use

5. Device Description

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6. Technology Characteristics

The design and construction of the Terason uSmart3200T is same to the Terason uSmart3200T Ultrasound system which was cleared in May 2013. These systems utilize a portable computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the tablet computer.

The uSmart3200T system contains the same ultrasound engine as the predicate device Terason T3200 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:

Three transducers have been added to the system. The software has been modified to . control these transducers and ensure compliance to the standards controlling acoustic and thermal power.
. Added support for 15L4, 16HL7 and 8EC4A transducers
- Confirmed transducer id numbers and names O
- Confirmed transducer geometries and characteristic parameters o
- o Confirmed 15L4 and 16HL7 acoustic tables and added 8EC4A acoustic tables
- Added 15L4, 16HL7 and 8EC4A to the table of allowed transducers o
- Added imaging presets for 15L4, 16HL7 and 8EC4A with o
  - Musculoskeletal selections same as offered on Terason t3200 B
  - . 8EC4A gynecological and prostate exams
  - l 15L4 same exam and preset selections as 12L5A
  - l Vascular exams and presets for 15L4 and 16HL7

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Added the Vascular Application series with new exam license files .
Added exam license files for gynecological and prostate exam types .
. Added the Enhanced Needle Visualization (ENV) feature as a licensed option, available only on the 15L4 transducer
. Added UI feature to optionally swap position of the Control Panel Area and the Thumbnail Area on the screen, left vs. right
Removed TGC Display from the General tab of Setup .
Added System Backup and Restore, initiated from the General tab of Setup ●
Added Gesture options to the General tab of Setup .
- o Disable All Gestures
- Enable Double Tap Gesture o
ECG options disable on General Tab of Setup .
Added measurement configurations for Spectral Doppler and M-mode. .
Added vessel name to the measurement configuration .
. Added feature to modify user annotations
In the Store/Acquire tab of Setup, added feature to enable retrospective acquisition of the . live image stream
. Disabled selection of ECG related features on the Store/Acquire tab of Setup
. Added DICOM communication option and features, Storage and Modality Worklist
. Changed designation of Clinician to Operator on the Patient screen
Added selection checkboxes to multiple selection list controls .
. Added touch gestures for multiple selection in list controls
Added touch gestures for freeze, play/pause, zoom and pan, depth, steering, split-� screen, spectral Doppler scale and baseline, color Doppler scale, review navigation, full screen, text and body markers
. Added variable sector size and position for the 4V2A transducer
Minor updates to soft key menus .
Modified 12L5A Musculoskeletal presets to be the same selections as offered on the . Terason t3200
. Added Musculoskeletal, Breast, Thyroid and Vascular Access exam measurements and annotations, same as offered on Terason t3200.
1. Table of Similarities and Differences Compared to the Predicate Devices

Terason uSmart3200T System and Transducers Comparison and Discussion (Transducers 8EC4A, 16HL7, and 15L4) and previously cleared 510(k) K131209 transducers (12L5A, 5C2A, and 4V2A)

Terason uSmart3200T Tablet Computer

Subject Device Model	Comparable PredicateDevice	Comparable PredicateDevices
Terason uSmart3200T	Terason uSmart3200TK1301209	Terason t3000K112953
(This Submission)

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Intended Use	Diagnostic Ultrasound	Diagnostic Ultrasound	Diagnostic Ultrasound
	imaging or fluid flow	imaging or fluid flow	imaging or fluid flow
	analysis of the human	analysis of the human	analysis of the human
	body	body	body
Indication for Use	Fetal, Abdominal, Intra-operative (Spec.),Pediatric, Small Organ(Thyroid, Breast, Testes,etc.), Neonatal Cephalic,Adult Cephalic, Trans-rectal, Trans-vaginal,Musculo-skel.(Convent.), Musculo-skel. (Superfic), CardiacAdult, Cardiac Pediatric,Peripheral vessel	Fetal, Abdominal,Pediatric, Small Organ(Thyroid, Breast, Testes,etc.), Neonatal Cephalic,Adult Cephalic, Musculo-skel. (Convent.),Musculo-skel. (Superfic),Cardiac Adult, CardiacPediatric, Peripheralvessel	Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro),Laparoscopic, Pediatric,Small Organ (Thyroid,Breast, Testes, etc.),Neonatal Cephalic,Adult Cephalic, Trans-rectal, Trans-vaginal,Musculo-skel.(Convent.), Musculo-skel. (Superficial),Cardiac Adult, CardiacPediatric, Peripheralvessel
Transducer Types	Linear ArrayCurved ArrayPhased ArrayEndocavity - curvedarrayHockey Stick - Linear	Linear ArrayCurved ArrayPhased ArrayEndocavity - curvedarray	Linear ArrayCurved ArrayPhased ArrayEndocavity - curvedarrayHockey Stick - LinearBi-plane -Linear/curved
Acoustic Output and	Display Features for	Display Features for	Display Features for
FDA Limits	High Outputs	High Outputs	High Outputs
Global MaximumOutputs/Worst CaseSetting	ISPTA3: 652.9 mW/cm²(4V2A)TI Type: TIC (15L4)TI Value: 5.8 (15L4)MI: 1.78 (8EC4A)IPA3@MI Max: 1029W/cm² (15L4)	ISPTA.3: 652.9 mW/cm²(4V2A)TI Type: TIB (4V2A)TI Value: 5.6 (4V2A)MI: 1.74 (4V2A)IPA3@MI Max: 350.3W/cm² (4V2A)	ISPTA.3: 678.1 mW/cm²(12HL7)TI Type: TIB (4V2A)TI Value: 5.6 (4V2A)MI: 1.5 (4V2A)IPA3@MI Max: 227.3W/cm² (4V2A)
Modes of Operation	B-Mode Grayscale	B-Mode Grayscale	B-Mode Grayscale
	Imaging	Imaging	Imaging
	Tissue Harmonic	Tissue Harmonic	Tissue Harmonic
	Imaging	Imaging	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
	Velocity Color Doppler	Velocity Color Doppler	Velocity Color Doppler
	Duplex/Triplex - Doppler	Duplex/Triplex - Doppler	Duplex/Triplex -
	imaging	imaging	Doppler imaging
	Pulsed Wave (PW)	Pulsed Wave (PW)	Pulsed Wave (PW)
	Doppler	Doppler	Doppler
	TeraVision II	TeraVision II	TeraVision I

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	Postprocessing	Postprocessing	Postprocessing
PW Doppler	Available for alltransducersTriplex ModeB-Mode and PWDopplerHigh PRF	Available for alltransducersTriplex ModeB-Mode and PWDopplerHigh PRF	Available for alltransducersTriplex ModeB-Mode and PWDopplerHigh PRF
Transducer Frequency	2.0 - 15.0 MHz	2.0 - 15.0 MHz	2.0 - 10.0 MHz
#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 -Image Viewer	DICOM 3.0 StructuredReporting, Worklist -Image Viewer	DICOM 3.0 Worklist -Image Viewer
Product SafetyCertification	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 touchscreen.Tablet dimensions(8.82"(H) x 12.64"(W) x1.25"(D)).A Lithium-Polymerbattery (integrated intothe tablet) provides 2hours of continuousultrasound scanningDocking station (forcharging) that uses amedical-grade powersupplyData transferred to thetablet computer over aFireWire (aka IEEE1394)	uSmart3200T:tablet computerweighs 4.9 lbs (2.21 Kg)11.5" backlit touchscreen.Tablet dimensions(8.82"(H) x 12.64"(W) x1.25"(D)).A Lithium-Polymerbattery (integrated intothe tablet) provides 2hours of continuousultrasound scanningDocking station (forcharging) that uses amedical-grade powersupplyData transferred to thetablet computer over aFireWire (aka IEEE1394)	Terason T3000:Laptop Computerweighs: 8.0 pounds (3.6kg), LED backlit displayand keyboard, Laptopdimensions (H): 2.5",(W): 13.8", (D): 11.0"A Lithium-Polymerbattery, (integrated intothe Laptop) provides 2hours of continuousultrasound scanning.Uses a medical-gradepower supplyData transferred to thelaptop computer over aFireWire (aka IEEE1394)

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There are no hardware design changes to the system (ultrasound engine and tablet computer). The hardware design released at the time original submission (K131209) already had all the necessary functions and features to support the changes in software and the additional 3 transducers. The hardware revisions of the ultrasound engine and tablet computer remain unchanged.

8EC4A Transducer

Key Features	Subject Device ModelTerason 8EC4ATransducer	ComparablePredicate DeviceTerason 8EC4ATransducer	Same or Different
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K112953	n/a
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(Terason uSmart3200T)to image trans-rectaland trans-vaginal.	The transducer isintended to be usedwith a conventionalultrasound system(Terason t3000) toimage trans-rectal andtrans-vaginal.	Same. The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.Effectiveness: Botharrays allow focused
Acoustic Array Style:	Endocavity CurvedArray	Endocavity CurvedArray	transmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	1286.50.205mm X 5.0mm30mm	1286.50.205mm X 5.0mm30mm	Same: element count.Acoustic characteristicshave met safetyguidelines of IEC60601-2-37. Safety andeffectivenessunchanged frompredicate.
Acoustic Array	The transducer imagingperformance has beenevaluated in an acoustictank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K112953).	Same; The 8EC4A usesa same acoustic arrayas the predicate deviceand therefore has sameacoustic characteristics.To ensure proper safetyguidelines are met,acoustic testing wasperformed per theIEC60601-2-37

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Patient ContactMaterial	ABS Silicone 747	ABS Silicone 747	Same

Discussion:

The 8EC4A uses a same acoustic array as the predicate 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 8EC4A 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 16HL7

Key Features	Subject Device ModelTerason 16HL7Transducer	Comparable PredicateDeviceTerason 16HL7Transducer	Same or Different
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K110020	n/a
Indications for Use	The transducer isintended to be used witha conventionalultrasound system(Terason uSmart3200T)to image intra-operative,small parts, muskulo-skel and peripheralvascular regions.	The transducer isintended to be usedwith a conventionalultrasound system(Terason t3200) toimage intra-operative,small parts, muskulo-skel and peripheralvascular regions.	Same. The proposedtransducer and thepredicate transducerhave the identicalclaim of imagingsimilar regions in thehuman body.
Acoustic ArrayTechnology	Piezoelectric elements	Piezoelectric elements	Same
Transducer Style	Hockey-Stick LinearArray	Hockey-Stick LinearArray	Same.
Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	1289.2 MHz0.2mm X 3.5mm12mm	1289.2 MHz0.2mm X 3.5mm12mm	Same.
Acoustic Output andDevice Settings	The transducer imagingperformance has beenevaluated in an acoustictank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K110020)	Same.

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Patient ContactMaterial	Silicone PEI	Silicone PEI	Same.

Discussion:

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 16HL7 transducer is substantially equivalent to the Terason 16HL7 transducer (K110020) with respect to safety and effectiveness.

15L4 Transducer

Key Features	Subject Device ModelTerason 15L4Transducer	ComparablePredicate DeviceTerason 15L4Transducer	Same or Different
510(k) Number	K140524	K110020	n/a
Classification	ITX	ITX	Same
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(TerasonuSmart3200T) to imageabdomen, small parts,musculo-skel andperipheral vascularregions.	The transducer isintended to be usedwith a conventionalultrasound system(Terason T3200) toimage abdomen, smallparts, musculo-skeland peripheralvascular regions.	Same: The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same: Safetyrequirements ofIEC60601 are equallymet.Effectiveness: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
Acoustic Array Style:	Linear Array	Linear Array

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Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	128 elements7.5 MHz0.3mm X 4.0mm20mm	128 elements7.5 MHz0.3mm X 4.0mm20mm	Same: element count.Acoustic characteristicshave met safetyguidelines of IEC60601-2-37.
Acoustic Output andDevice Settings	The transducer imagingperformance has beenevaluated in anacoustic tank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K110020).	Same; acoustic outputsafety guidelines. Safetyis not compromised.Effectiveness equal.
Patient Contact Material	The transducer usesSilicone SIM R1001 asa contact material.	The transducer usesSilicone SIM R1001 asa contact material.	Same. The 15L4transducer consists ofsame patient contactmaterials as thepredicate device. Thesafety of each devicewith respect tobiocompatibility isequivalent.

Discussion:

The 15L4 uses a same acoustic array than the predicate 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 15L4 transducer consists of same patient contact materials as the predicate device.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4 transducer is substantially equivalent to the Terason 15L4 transducer (K110020) with respect to safety and effectiveness.

Transducers previously cleared in submission K131209

12L5A Transducer

Key Features	Subject Device Model	Comparable PredicateDevice	Same or Different
	Terason 12L5A	Terason 12L5A

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	Transducer	Transducer
DeviceClassification	ITX	ITX	Same
510(k) Number	KXXXXXX	K131209	n/a
Indications forUse	The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3200T) to imageFetal, Abdominal,Pediatric, Small Organ,Cephalic, Musculo-skel,Cardiac and Peripheralvessel.	The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3200T) to imageFetal, Abdominal,Pediatric, Small Organ,Cephalic, Musculo-skel,Cardiac, and Peripheralvessel.	Same. The proposedtransducer and thepredicate transducer havethe identical claim ofimaging similar regions inthe human body.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.
Acoustic ArrayStyle:	Linear Array	Linear Array	Regarding Safety: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhance imagequality within the region ofinterest.
Acoustic ArrayCharacteristics:			Same in elevationSafety and effectivenessunchanged from predicate
Element count...	128	128
Centerfrequency...	7.5	7.5
Element size(pitch xelevation)...	0.3mm X 4.0mm	0.3mm X 4.0mm
Elevationfocus...	19mm	19mm
Acoustic Array	The transducer imagingperformance has beenevaluated in an acoustictank.	The transducerperformance has beenevaluated in the previous510(k) filing (K131209).	Same. As the predicatedevice and therefore hassame acousticcharacteristics. To ensureproper safety guidelinesare met, acoustic testing
			was performed per theIEC60601-2-37 standard.
Patient ContactMaterial	Silicone ABS	Silicone ABS	Same. The 12L5Atransducer consists ofsame patient contactmaterials as the predicatedevice.

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5C2A Transducers

Key Features	Subject Device Model	ComparablePredicate Device	Same or Different
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXX	K131209	n/a
Indications for Use	The transducer isintended to be usedwith a conventionalultrasound system(TerasonuSmart3200T) toimage Fetal,Abdominal, Pediatric,Small Organ, Cephalic,Musculo-skel, Cardiacand Peripheral vessel.	The transducer isintended to be usedwith a conventionalultrasound system(TerasonuSmart3200T) toimage Fetal,Abdominal, Pediatric,Small Organ, Cephalic,Musculo-skel, Cardiac,and Peripheral vessel.	Same. The proposedtransducer and thepredicate transducerhave the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.
Acoustic Array Style:	Curved Array	Curved Array	Regarding Safety: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
	Terason 5C2ATransducer	Terason 5C2ATransducer

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Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus...	1283.50.5mm X 13.0mm80mm	1283.50.5mm X 13.0mm80mm	Same in elevationSafety and effectivenessunchanged frompredicate
Acoustic Array	The transducerimaging performancehas been evaluated inan acoustic tank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K131209).	Same. As the predicatedevice and therefore hasdifferent acousticcharacteristics. Toensure proper safetyguidelines are met,acoustic testing wasperformed per theIEC60601-2-37 standard.
Patient ContactMaterial	Silicone ABS	Silicone ABS	Same. The 5C2Atransducer consists ofsame patient contactmaterials as thepredicate device.

4V2A Transducer

Key Features	Subject Device ModelTerason 4V2ATransducer	Comparable PredicateDeviceTerason 4V2ATransducer	Same or Different
Device Classification	ITX	ITX	Same
510(k) Number	K1XXXXXX	K131209	n/a
Indications for Use	The transducer isintended to be usedwith a conventional	The transducer isintended to be usedwith a conventional	Same. The proposedtransducer and thepredicate transducer
	ultrasound system(TerasonuSmart3200T) to imageFetal, Abdominal,Pediatric, Small Organ,Cephalic, and Cardiac.	ultrasound system(TerasonuSmart3200T) to imageFetal, Abdominal,Pediatric, Small Organ,Cephalic, and Cardiac.	have the identical claimof imaging similarregions in the humanbody.
Acoustic ArrayTechnology:	Piezoelectric elements	Piezoelectric elements	Same.
Acoustic Array Style:	Phased Array	Phased Array	Regarding Safety: Botharrays allow focusedtransmission andreception of ultrasoundenergy to enhanceimage quality within theregion of interest.
Acoustic ArrayCharacteristics:Element count...	64	64	Same in elevationSafety andeffectivenessunchanged frompredicate
Center frequency...	2.8	2.8
Element size (pitch xelevation)...	256 microns X 12mm	256 microns X 12mm
Elevation focus...	16.3mm	16.3mm
Acoustic Array	The transducer imagingperformance has beenevaluated in anacoustic tank.	The transducerperformance has beenevaluated in theprevious 510(k) filing(K131209).	Same. As the predicatedevice and thereforehas different acousticcharacteristics. Toensure proper safetyguidelines are met,acoustic testing wasperformed per theIEC60601-2-37standard.
Patient ContactMaterial	Silicone Valox	Silicone Valox	Same. The 4V2Atransducer consists ofsame patient contactmaterials as thepredicate device.

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Accessories / Kits:

・

: ・

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uSmart3200TTransducer	AccessoryDescription	Manufacturer / Part #	FDA 510k Clearance #
8EC4A	Biopsy Kit	Civco #610-605	K970514
8EC4A	Sterile Sheath	Civco #610-001	K970513
16HL7	Sterile Sheath	Civco #610-797	K013721
15L4	Biopsy Kit	Civco #612-085	K882383/A
15L4	Sterile Sheath	Civco #610-002	K970513

Conclusion

The intended uses and features are consistent with the traditional clinical practices and FDA guidance for clearance of Diagnostic ultrasound systems and transducers. The uSmart3200T and predict 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 as noted above.

8. Non Clinical Tests

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

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety. . Intertek Test Record Number 100825075BOX-001. o
. IEC 62366, Medical Devices: Application of usability engineering to medical devices. o Intertek Project: 100825075BOX-004A.
IEC60601-1-6. Medical Electrical Equipment Part 1-6. General requirements for . safety- Collateral standard: Usability
- Intertek Project: 100825075BOX-003A. o
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
- IEC60601-1-2 Test Record Number, 100933162BOX-017 o
- Radiated Emissions CISPR11 Class B @10m Report Number o 101224397BOX-001 on uSmart3200T 8EC4 and 16HL7
- Radiated Emissions CISPR11 Class B @10m Report Number o 101188849BOX-001a on uSmart3200T 15L4 Transducer
. IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- o Transducer Model 15L4: Intertek Report #100404852BOX-002

{14}------------------------------------------------

K140524
Page 15 of 15

Transducer Model 16HL7 Intertek Report #100404852BOX-004 o
Transducer Model 8EC4A Intertek Report #100404852BOX-003 o
NEMA UD 3 Acoustic Output Display .

�

Terason uSmart3200T Ultrasound System User Guide (16-3301)
Biocompatibility Tests, ISO 10993 Part 5 and Part 10
- Biocompatibility reports for the three new transducers included in this o submission.
AAMI TIR No. 12:210, Designing, Testing and Labeling Reusable Medical Devices . for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21. 2014

TERATECH CORP. % MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES, LLC 1394 257"1 STREET NW BUFFALO MN 55313

Re: K140524

Trade/Device Name: Terason uSmart3200T and BenQ UP200 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. IYO, ITX Dated: February 20, 2014 Received: March 4, 2014

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.

If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

{16}------------------------------------------------

Page 2-Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{17}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See P R A Statement on last page.

510(k) Number (if known) K140524

Device Name

Terason uSmart3200T and BenQ UP200 Ultrasound System

Indications for Use (Describe)

Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (abdominal, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

Type of Use (Select one or both, as applicable)
	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 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 8	P S C Publishing Services (301) 443-6740 EF
----------------------	-------------	---------------------------------------------

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Indications For Use: Diagnostic ultrasound Imaging system of fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & 111)	B	M	PWD	CWD	ColorDoppa	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	N	N	N		N	N	N
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid,Breast, Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicd:	P1	P1	P1		P1	P1	P1
	Adult Cephalicd:	P1	P1	P1		P1	P1	P1
	Trans-rectalf:	N	N	N		N	N	N
	Trans-vaginalg:	N	N	N		N	N	N
	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	P1	P1	P1		P1	P1	P1
	Cardiac Pediatric	P1	P1	P1		P1	P1	P1
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

Device Name: __Terason uSmart3200T and BenQ UP200 Ultrasound System Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

N= new indicalion; P= previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, cathelers.

" Abdominal, thoracic and peripheral vessel.

'Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P3: uses previously cleared under K131209.

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Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Terason uSmart3200T and BenQ UP200 - 15L4 Transducer Indications For Use: Diagnostic ultrasound imaging system or fluid llow analysis of the human body as follows:

Clinical Application		Mode of Operation
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
General(Track I Only)	Ophthalmic
Ophthalmic	Fetalh
FetalImaging& Other	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricc:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid,Breast, Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicc:
	Adult Cephalicd:
	Trans-rectali:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)o:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)o:	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

Anchew more and Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler,

8 +M: B+PWD; B+CD; B+DPD; B+PD.

Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, thoracic and peripheral vessel.

'Includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy

· Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Additional Comments: P': uses previously cleared under K110020

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Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e	P1	P1	P1		P1	P1	P1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricc:
	Small Organ (Thyroid,Breast, Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicc:
	Adult Cephalicc:
	Trans-rectali:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)g:	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)

Device Name: _Terason.uSmart3200T and BenQ UP200 - 16HLZ Transducer

N= new indication; P= previously cleared by FDA; E= added under Appendix E

" Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8 +M, B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

° Abdominal, thoracic and peripheral vessel.

Includes ultrasound guidance for placement of needles, catherers, cryosurgery, and brachytherapy

Includes ultrasound guidance of placeminal biopsy, intertility montoring of follicie development.
Planet of transvand guidance of transvaginal biopsy, intentility months and

" Includes guidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P1: uses previously cleared under K110020

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Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Terason uSmart3200T and BenQ UP200 - 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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:
	Intra-operative (Spec.)d,6
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricd:
	Small Organ (Thyroid,Breast, Testes, etc.)d:
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:	P1	P1	P1		P1	P1	P1
	Trans-vaginalg:	P1	P1	P1		P1	P1	P1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:
	Musculo-skel. (Superfic)g:
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseld:
	Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

0 B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal, thoracic and peripheral vessel.

' Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, intentility monitoring of follicle development.

" Includes guidance of amniocentesis, inferility monitoring of follicle development.

Additional Comments: P : uses previously cleared under K112953

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): __

Device Name: _Terason uSmart3200T and BenQ UP200 - 5C2A Transducer

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Comb.	Other
(Track I Only)	(Tracks I & III)					Dopp®	Modes®
Ophthalmic	Ophthalmic
	Fetal"	pir	prz	priz		pT.2	prz	వారి
	Abdominal®:	piri	prz	prz		PT.2	prz	prz
	Intra-operative (Spec.) ".
	Intra-operative (Neuro)
	Laparoscopic
Fetal	Pediatric®:	PT.Z	prz	pT.2		pT.2	PTZ	prz
Imaging	Small Organ (Thyroid,
& Other	Breast, Testes, etc.)":
	Neonatal Cephalic®:
	Adult Cephalic®:
	Trans-rectal':
	Trans-vaginal®:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.) °:	p	pa	ps		p	p	p
	Musculo-skel. (Superfic)":	pr	p	ದ		pe	Dr	p
	Intra-luminal
	Other (Specify)
	Cardiac Adult	ps	pr	p2		p	P	p
Cardiac	Cardiac Pediatric	p2	p2	pe		പ്ര	p	pr
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral	Peripheral vessel®:	p7.2	pirs	pr.2		pT2	pT.2	p1.2
Vessel	Other (Specify)

N= new indication: P= previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8 +M; B+PWD; B+CD; B+DPD; 8+PD.

6 Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

" Abdominal, thoracic and peripheral vessel.

'Includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, intertilly monitoring of follicle development.

" Includes quidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P': uses previously cleared under K112953
Additional Comments: P': uses previously cleared under K131209

²: uses previously cleared under K131209

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Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): __

Device Name: _Terason uSmart3200T and BenQ UP200 - 12L5A Transducer

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
General(Track I Only)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh
	Abdominali:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Intra-operative (Spec.)d,a
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricc:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Small Organ (Thyroid,Breast, Testes, etc.)d:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Neonatal Cephalicc:	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-rectali:
	Trans-vaginali:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)o:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Musculo-skel. (Superfic)o:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesseli:	P1.2	P1.2	P1.2		P1.2	P1.2	P1.2
	Other (Specify)

Na new indication; P= previously cleared by FDA; E= added under Appendix E

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8 +M: B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, Ihoracic and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, intertility monitoring of folicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

Additional Comments: P': uses previously cleared under K112953

P3: uses previously cleared under K131209

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetalh	p1,2	p1,2	p1,2		p1,2	p1,2	p1,2
	Abdominali:	p1,2	p1,2	p1,2		p1,2	p1,2	p1,2
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatrico:	p1,2	p1,2	p1,2		p1,2	p1,2	p1,2
	Small Organ (Thyroid,Breast, Testes, etc.)d:
	Neonatal Cephalico:	p1,2	p1,2	p1,2		p1,2	p1,2	p1,2
	Adult Cephalico:	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.)o:
	Musculo-skel. (Superfic)o:
	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)

Device Name: __Terason uSmart3200T and BenQ UP200 - 4V2A Transducer

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follow

N= new indication: P= previously cleared by FDA; E= added under Appendix E " Includes Color Dopplar (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

B+M; B+PWD; B+CD; B+DPD; B+PD.

"B+M; B+PWD; B+CD; B+DP"
Electronic Imaging (EI)

' Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

· Abdominal, thoracic and peripheral vessel.

Includes ultrasound guidance for placement of needles, cathelers, cryosurgery, and brachytherapy

Includes ultrasound guidance of placement of invelser of your and only and the revelopment.

" Includes guidance of amniocentesis, intertility monitoring of follicle development.

Additional Comments: P': uses previously cleared under K112953 P2: uses previously cleared under K131209

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health

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.