MOBILEDIAGNOST WDR
FDA 510(k) clearance K111725 · decided 2011-07-19
Clearance details
- K-number
- K111725
- Device name
- MOBILEDIAGNOST WDR
- Applicant
- Sedecal., Sa.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-20
- Decision date
- 2011-07-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seneca, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system recall (Z-0243-2026) | SEDECAL SA | 2025-10-23 |
| MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 recall (Z-1083-2024) | SEDECAL SA | 2024-02-14 |
| MobileDiagnost wDR motorized portable diagnostic X-ray systems. recall (Z-1040-2015) | Sedecal S.A. | 2015-02-02 |
| Intended for both adult and pediatric patients for taking diagnostic radiographic exposure recall (Z-0508-2015) | Philips Medical Systems, Inc. | 2014-12-16 |
| Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Produ recall (Z-1964-2013) | Philips Healthcare Inc. | 2013-08-21 |