DEVICE: INTERVENTIONAL ANGIOGRAPHY SYSTEM (04987670100222)
Device Identifier (DI) Information
INTERVENTIONAL ANGIOGRAPHY SYSTEM
INFX-8000V
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
INFX-8000V
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
INTERVENTIONAL ANGIOGRAPHY SYSTEM
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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37623 | Stationary angiographic x-ray system, digital |
A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OWB | Interventional fluoroscopic x-ray system |
JAA | System, x-ray, fluoroscopic, image-intensified |
IZI | System, x-ray, angiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K152696 | 000 |
K162614 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b465917d-66e3-4848-b36a-1215f24f8678
July 06, 2018
3
September 01, 2016
July 06, 2018
3
September 01, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+1-8004211968
xxx@xxx.xxx
xxx@xxx.xxx