DEVICE: SonoSite M-Turbo (00841517100032)
Device Identifier (DI) Information
SonoSite M-Turbo
P17000-15
In Commercial Distribution
FUJIFILM SONOSITE, INC.
P17000-15
In Commercial Distribution
FUJIFILM SONOSITE, INC.
Diagnostic ultrasound system
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40761 | General-purpose ultrasound imaging system |
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
|
Active | false |
40764 | Breast ultrasound imaging system |
An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.
|
Active | false |
40762 | Obstetrical/gynaecological ultrasound imaging system |
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) obstetrical and gynaecological (OB/GYN) imaging procedures. It includes software packages to support a variety of static and real-time OB/GYN imaging applications involving foetal imaging, amniocentesis procedures and uterine imaging. The system generates ultrasound pulses, directs them to the target area, detects the ultrasound echoes, and processes the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images of human anatomy. It is also used to guide and confirm placement of other medical instruments in use.
|
Active | false |
40763 | Cardiovascular ultrasound imaging system |
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYN | System, imaging, pulsed doppler, ultrasonic |
ITX | Transducer, ultrasonic, diagnostic |
IYO | System, imaging, pulsed echo, ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130173 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
dad998ce-1ca6-4c12-aa36-f697b10a9d3a
May 10, 2021
5
September 13, 2016
May 10, 2021
5
September 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-657-8118
ffss-service@fujifilm.com
ffss-service@fujifilm.com