DEVICE: Angio Workstation Software (04987670100451)

Device Identifier (DI) Information

Angio Workstation Software
XIDF-AWS801
In Commercial Distribution

CANON MEDICAL SYSTEMS CORPORATION
04987670100451
GS1

1
690575113 *Terms of Use
Angio Workstation Software
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
58473 Diagnostic x-ray digital imaging system workstation application software
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JAA System, x-ray, fluoroscopic, image-intensified
OWB Interventional fluoroscopic x-ray system
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152785 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bcd0dca7-0d96-437f-8e80-6f69c0f4f0ba
July 06, 2018
3
September 01, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1-8004211968
xxx@xxx.xxx
CLOSE