DEVICE: DIAGNOSTIC X-RAY SYSTEM KALARE (04987670100116)
Device Identifier (DI) Information
DIAGNOSTIC X-RAY SYSTEM KALARE
DREX-KL80
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
DREX-KL80
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
DIAGNOSTIC X-RAY SYSTEM KALARE
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? |
---|---|---|---|---|
40658 | Fluoroscopy/angiography table, powered |
A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAA | System, x-ray, fluoroscopic, image-intensified |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133553 | 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
cbd1263a-25cd-49b0-be89-f4bcf088c41d
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 |
---|---|---|---|---|---|
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