DEVICE: REGIUS Cassette (04560141928329)
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? |
|---|---|---|---|---|
| 44823 | Digital imaging cassette |
A device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.
|
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 |
|---|
| Device Size Text, specify: 14" x 42" |
Device Record Status
b14d1a16-a274-4f4a-9d06-995fe1a4c104
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