DEVICE: REGIUS Plate (04560141931381)
Device Identifier (DI) Information
Device Characteristics
MR Unsafe | |
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? |
---|---|---|---|---|
44826 | Digital imaging storage phosphor screen |
A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092717 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 18cm x 24cm |
Device Record Status
ee285e2d-d3a5-45f9-9715-9ad8aa5889b4
February 03, 2023
4
September 19, 2016
February 03, 2023
4
September 19, 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
[?]
No Customer Contact currently defined