DX-D 600
FDA 510(k) clearance K112670 · decided 2011-10-27
Clearance details
- K-number
- K112670
- Device name
- DX-D 600
- Applicant
- Agfa Healthcare N.V.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-14
- Decision date
- 2011-10-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenville, SC, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray recall (Z-3245-2018) | Agfa N.V. | 2018-09-25 |
| DX-D600 - DXD Imaging Package recall (Z-1738-2017) | AGFA Healthcare Corp. | 2017-04-05 |
| DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic recall (Z-2175-2014) | AGFA Healthcare Corp. | 2014-08-10 |