DX-D IMAGING PACKAGE
FDA 510(k) clearance K092669 · decided 2009-11-06
Clearance details
- K-number
- K092669
- Device name
- DX-D IMAGING PACKAGE
- Applicant
- Agfa Healthcare N.V.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-31
- Decision date
- 2009-11-06
- Days to decision
- 67 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correcti recall (Z-1062-2012) | AGFA Corp. | 2012-02-19 |