CR 10-X DIGITIZER
FDA 510(k) clearance K121948 · decided 2012-07-20
Clearance details
- K-number
- K121948
- Device name
- CR 10-X DIGITIZER
- Applicant
- Agfa Healthcare N.V.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-03
- Decision date
- 2012-07-20
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mortsel, BE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image recall (Z-0970-2013) | AGFA Corp. | 2013-03-19 |