(17 days)
No
The document describes standard ultrasound image processing and does not mention AI, ML, or related terms.
No
Explanation: This device is described as a diagnostic ultrasound system intended for imaging and fluid flow analysis, not for treating conditions.
Yes
The "Device Description" section explicitly states that the Terason uSmart3200T ultrasound system is a "diagnostic ultrasound system."
No
The device description clearly outlines hardware components including a portable tablet, transducers, a proprietary ultrasound engine, a battery, and a docking station. It is a physical ultrasound system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Terason uSmart3200T is an ultrasound system. It uses sound waves to create images of internal structures of the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body," not for analyzing biological samples.
- Device Description: The description focuses on the hardware and how it acquires and processes ultrasound data, not on laboratory analysis of specimens.
Therefore, the Terason uSmart3200T falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
IYN, IYO, ITX
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 medical-grade 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Neonatal, Pediatric, Adult
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Terason 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.
- IEC 62366, Medical Devices: Application of usability engineering to medical devices. Intertek Project: 100825075BOX-004A.
- IEC60601-1-6. Medical Electrical Equipment Part 1-6. General requirements for safety- Collateral standard: Usability Intertek Project: 100825075BOX-003A.
- 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
- Radiated Emissions CISPR11 Class B @10m Report Number 101224397BOX-001 on uSmart3200T 8EC4 and 16HL7
- Radiated Emissions CISPR11 Class B @10m Report Number 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.
- Transducer Model 15L4: Intertek Report #100404852BOX-002
- Transducer Model 16HL7 Intertek Report #100404852BOX-004
- Transducer Model 8EC4A Intertek Report #100404852BOX-003
- 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 submission.
- AAMI TIR No. 12:210, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
5. Device Description
1
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.
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
2
- 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.
-
- 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 Predicate
Device | Comparable Predicate
Devices |
|----------------------|---------------------------------|---------------------------------|
| Terason uSmart3200T | Terason uSmart3200T
K1301209 | Terason t3000
K112953 |
| (This Submission) | | |
3
| 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), Cardiac | |||
| Adult, 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, Cardiac | |||
| Pediatric, Peripheral | |||
| vessel | 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, Cardiac | |||
| Pediatric, Peripheral | |||
| vessel | |||
| Transducer Types | Linear Array | ||
| Curved Array | |||
| Phased Array | |||
| Endocavity - curved | |||
| array | |||
| Hockey Stick - Linear | Linear Array | ||
| Curved Array | |||
| Phased Array | |||
| Endocavity - curved | |||
| array | Linear Array | ||
| Curved Array | |||
| Phased Array | |||
| Endocavity - curved | |||
| array | |||
| Hockey Stick - Linear | |||
| Bi-plane -Linear/curved | |||
| Acoustic Output and | Display Features for | Display Features for | Display Features for |
| FDA Limits | High Outputs | High Outputs | High Outputs |
| Global Maximum | |||
| Outputs/Worst Case | |||
| Setting | ISPTA3: 652.9 mW/cm² | ||
| (4V2A) | |||
| TI Type: TIC (15L4) | |||
| TI Value: 5.8 (15L4) | |||
| MI: 1.78 (8EC4A) | |||
| IPA3@MI Max: 1029 | |||
| W/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: 350.3 | |||
| W/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: 227.3 | |||
| W/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 |
:
・
t
.
:
:
4
| Postprocessing | Postprocessing | Postprocessing | |
|---|---|---|---|
| PW Doppler | Available for all | ||
| transducers | |||
| Triplex Mode | |||
| B-Mode and PW | |||
| Doppler | |||
| High PRF | Available for all | ||
| transducers | |||
| Triplex Mode | |||
| B-Mode and PW | |||
| Doppler | |||
| High PRF | Available for all | ||
| transducers | |||
| Triplex Mode | |||
| B-Mode and PW | |||
| Doppler | |||
| High 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 Output | |||
| Measurement Standard | NEMA UD 2-2004 | ||
| NEMA UD 3-2004 | NEMA UD 2-2004 | ||
| NEMA UD 3-2004 | NEMA UD 2-2004 | ||
| NEMA UD 3-2004 | |||
| DICOM | DICOM 3.0 Structured | ||
| Reporting, Worklist - | |||
| Image Viewer | DICOM 3.0 Structured | ||
| Reporting, Worklist - | |||
| Image Viewer | DICOM 3.0 Worklist - | ||
| Image Viewer | |||
| Product Safety | |||
| Certification | IEC60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-1-6 | |||
| IEC60601-2-37 | IEC60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-1-6 | |||
| IEC60601-2-37 | IEC60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-1-4 | |||
| IEC60601-2-37 | |||
| EMC | IEC60601-1-2 | ||
| CISPR11 Class B | IEC60601-1-2 | ||
| CISPR11 Class B | IEC60601-1-2 | ||
| CISPR11 Class B | |||
| System | |||
| Characteristics | uSmart3200T: | ||
| tablet computer | |||
| weighs 4.9 lbs (2.21 Kg) | |||
| 11.5" backlit touch | |||
| screen. | |||
| Tablet dimensions | |||
| (8.82"(H) x 12.64"(W) x | |||
| 1.25"(D)). | |||
| A Lithium-Polymer | |||
| battery (integrated into | |||
| the tablet) provides 2 | |||
| hours of continuous | |||
| ultrasound scanning | |||
| Docking station (for | |||
| charging) that uses a | |||
| medical-grade power | |||
| supply | |||
| Data transferred to the | |||
| tablet computer over a | |||
| FireWire (aka IEEE |
- | uSmart3200T:
tablet computer
weighs 4.9 lbs (2.21 Kg)
11.5" backlit touch
screen.
Tablet dimensions
(8.82"(H) x 12.64"(W) x
1.25"(D)).
A Lithium-Polymer
battery (integrated into
the tablet) provides 2
hours of continuous
ultrasound scanning
Docking station (for
charging) that uses a
medical-grade power
supply
Data transferred to the
tablet computer over a
FireWire (aka IEEE - | Terason T3000:
Laptop Computer
weighs: 8.0 pounds (3.6
kg), LED backlit display
and keyboard, Laptop
dimensions (H): 2.5",
(W): 13.8", (D): 11.0"
A Lithium-Polymer
battery, (integrated into
the Laptop) provides 2
hours of continuous
ultrasound scanning.
Uses a medical-grade
power supply
Data transferred to the
laptop computer over a
FireWire (aka IEEE - |
:
:
:
:
.
.
.
5
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 Model
Terason 8EC4A
Transducer | Comparable
Predicate Device
Terason 8EC4A
Transducer | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K112953 | n/a |
| Indications for Use | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason uSmart3200T)
to image trans-rectal
and trans-vaginal. | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason t3000) to
image trans-rectal and
trans-vaginal. | Same. The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human
body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same.
Effectiveness: Both
arrays allow focused
|
| Acoustic Array Style: | Endocavity Curved
Array | Endocavity Curved
Array | transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest. |
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus... | 128
6.5
0.205mm X 5.0mm
30mm | 128
6.5
0.205mm X 5.0mm
30mm | Same: element count.
Acoustic characteristics
have met safety
guidelines of IEC60601-
2-37. Safety and
effectiveness
unchanged from
predicate. |
| Acoustic Array | The transducer imaging
performance has been
evaluated in an acoustic
tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K112953). | Same; 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 |
6
| Patient Contact
| Material | 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 Model
Terason 16HL7
Transducer | Comparable Predicate
Device
Terason 16HL7
Transducer | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K110020 | n/a |
| Indications for Use | The transducer is
intended to be used with
a conventional
ultrasound system
(Terason uSmart3200T)
to image intra-operative,
small parts, muskulo-
skel and peripheral
vascular regions. | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason t3200) to
image intra-operative,
small parts, muskulo-
skel and peripheral
vascular regions. | Same. The proposed
transducer and the
predicate transducer
have the identical
claim of imaging
similar regions in the
human body. |
| Acoustic Array
Technology | Piezoelectric elements | Piezoelectric elements | Same |
| Transducer Style | Hockey-Stick Linear
Array | Hockey-Stick Linear
Array | Same. |
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus... | 128
9.2 MHz
0.2mm X 3.5mm
12mm | 128
9.2 MHz
0.2mm X 3.5mm
12mm | Same. |
| Acoustic Output and
Device Settings | The transducer imaging
performance has been
evaluated in an acoustic
tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K110020) | Same. |
7
| Patient Contact
| Material | 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 Model
Terason 15L4
Transducer | Comparable
Predicate Device
Terason 15L4
Transducer | Same or Different |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140524 | K110020 | n/a |
| Classification | ITX | ITX | Same |
| Indications for Use | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason
uSmart3200T) to image
abdomen, small parts,
musculo-skel and
peripheral vascular
regions. | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason T3200) to
image abdomen, small
parts, musculo-skel
and peripheral
vascular regions. | Same: The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human
body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same: Safety
requirements of
IEC60601 are equally
met.
Effectiveness: Both
arrays allow focused
transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest. |
| Acoustic Array Style: | Linear Array | Linear Array | |
8
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus... | 128 elements
7.5 MHz
0.3mm X 4.0mm
20mm | 128 elements
7.5 MHz
0.3mm X 4.0mm
20mm | Same: element count.
Acoustic characteristics
have met safety
guidelines of IEC60601-
2-37. |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic Output and
Device Settings | The transducer imaging
performance has been
evaluated in an
acoustic tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K110020). | Same; acoustic output
safety guidelines. Safety
is not compromised.
Effectiveness equal. |
| Patient Contact Material | The transducer uses
Silicone SIM R1001 as
a contact material. | The transducer uses
Silicone SIM R1001 as
a contact material. | Same. The 15L4
transducer consists of
same patient contact
materials as the
predicate device. The
safety of each device
with respect to
biocompatibility is
equivalent. |
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 Predicate
Device | Same or Different |
|--------------|----------------------|--------------------------------|-------------------|
| | Terason 12L5A | Terason 12L5A | |
9
| Transducer | Transducer | ||
|---|---|---|---|
| Device | |||
| Classification | ITX | ITX | Same |
| 510(k) Number | KXXXXXX | K131209 | n/a |
| Indications for | |||
| Use | The transducer is intended | ||
| to be used with a | |||
| conventional ultrasound | |||
| system (Terason | |||
| uSmart3200T) to image | |||
| Fetal, Abdominal, | |||
| Pediatric, Small Organ, | |||
| Cephalic, Musculo-skel, | |||
| Cardiac and Peripheral | |||
| vessel. | The transducer is intended | ||
| to be used with a | |||
| conventional ultrasound | |||
| system (Terason | |||
| uSmart3200T) to image | |||
| Fetal, Abdominal, | |||
| Pediatric, Small Organ, | |||
| Cephalic, Musculo-skel, | |||
| Cardiac, and Peripheral | |||
| vessel. | Same. The proposed | ||
| transducer and the | |||
| predicate transducer have | |||
| the identical claim of | |||
| imaging similar regions in | |||
| the human body. | |||
| Acoustic Array | |||
| Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array | |||
| Style: | Linear Array | Linear Array | Regarding Safety: Both |
| arrays allow focused | |||
| transmission and | |||
| reception of ultrasound | |||
| energy to enhance image | |||
| quality within the region of | |||
| interest. | |||
| Acoustic Array | |||
| Characteristics: | Same in elevation | ||
| Safety and effectiveness | |||
| unchanged from predicate | |||
| Element count... | 128 | 128 | |
| Center | |||
| frequency... | 7.5 | 7.5 | |
| Element size | |||
| (pitch x | |||
| elevation)... | 0.3mm X 4.0mm | 0.3mm X 4.0mm | |
| Elevation | |||
| focus... | 19mm | 19mm | |
| Acoustic Array | The transducer imaging | ||
| performance has been | |||
| evaluated in an acoustic | |||
| tank. | The transducer | ||
| performance has been | |||
| evaluated in the previous | |||
| 510(k) filing (K131209). | Same. 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. | |||
| Patient Contact | |||
| Material | Silicone ABS | Silicone ABS | Same. The 12L5A |
| transducer consists of | |||
| same patient contact | |||
| materials as the predicate | |||
| device. |
.
.
10
5C2A Transducers
| Key Features | Subject Device Model | Comparable
Predicate Device | Same or Different |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K131209 | n/a |
| Indications for Use | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason
uSmart3200T) to
image Fetal,
Abdominal, Pediatric,
Small Organ, Cephalic,
Musculo-skel, Cardiac
and Peripheral vessel. | The transducer is
intended to be used
with a conventional
ultrasound system
(Terason
uSmart3200T) to
image Fetal,
Abdominal, Pediatric,
Small Organ, Cephalic,
Musculo-skel, Cardiac,
and Peripheral vessel. | Same. The proposed
transducer and the
predicate transducer
have the identical claim
of imaging similar
regions in the human
body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array Style: | Curved Array | Curved Array | Regarding Safety: Both
arrays allow focused
transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest. |
| | Terason 5C2A
Transducer | Terason 5C2A
Transducer | |
11
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus... | 128
3.5
0.5mm X 13.0mm
80mm | 128
3.5
0.5mm X 13.0mm
80mm | Same in elevation
Safety and effectiveness
unchanged from
predicate |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic Array | The transducer
imaging performance
has been evaluated in
an acoustic tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K131209). | Same. As the predicate
device and therefore has
different acoustic
characteristics. To
ensure proper safety
guidelines are met,
acoustic testing was
performed per the
IEC60601-2-37 standard. |
| Patient Contact
Material | Silicone ABS | Silicone ABS | Same. The 5C2A
transducer consists of
same patient contact
materials as the
predicate device. |
.
.
.
4V2A Transducer
| Key Features | Subject Device Model
Terason 4V2A
Transducer | Comparable Predicate
Device
Terason 4V2A
Transducer | Same or Different |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXXX | K131209 | n/a |
| Indications for Use | The transducer is
intended to be used
with a conventional | The transducer is
intended to be used
with a conventional | Same. The proposed
transducer and the
predicate transducer |
| | ultrasound system
(Terason
uSmart3200T) to image
Fetal, Abdominal,
Pediatric, Small Organ,
Cephalic, and Cardiac. | ultrasound system
(Terason
uSmart3200T) to image
Fetal, Abdominal,
Pediatric, Small Organ,
Cephalic, and Cardiac. | have the identical claim
of imaging similar
regions in the human
body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same. |
| Acoustic Array Style: | Phased Array | Phased Array | Regarding Safety: Both
arrays allow focused
transmission and
reception of ultrasound
energy to enhance
image quality within the
region of interest. |
| Acoustic Array
Characteristics:
Element count... | 64 | 64 | Same in elevation
Safety and
effectiveness
unchanged from
predicate |
| Center frequency... | 2.8 | 2.8 | |
| Element size (pitch x
elevation)... | 256 microns X 12mm | 256 microns X 12mm | |
| Elevation focus... | 16.3mm | 16.3mm | |
| Acoustic Array | The transducer imaging
performance has been
evaluated in an
acoustic tank. | The transducer
performance has been
evaluated in the
previous 510(k) filing
(K131209). | Same. As the predicate
device and therefore
has different acoustic
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 4V2A
transducer consists of
same patient contact
materials as the
predicate device. |
12
Accessories / Kits:
・
: ・
13
| uSmart3200T
Transducer | Accessory
Description | 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 |
|---|---|---|
| ---------------------- | ------------- | --------------------------------------------- |
18
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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| General | ||||||||
| (Track I Only) | Ophthalmic | |||||||
| Ophthalmic | Fetalh | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,6 | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
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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
1
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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| General | ||||||||
| (Track I Only) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
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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 | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
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