SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
FDA 510(k) clearance K101517 · decided 2011-08-05
Clearance details
- K-number
- K101517
- Device name
- SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
- Applicant
- Sedecal., Sa.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-02
- Decision date
- 2011-08-05
- Days to decision
- 429 days
- Clearance type
- Special
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) recall (Z-0242-2026) | SEDECAL SA | 2025-10-23 |
| RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by recall (Z-2390-2015) | Sedecal S.A. | 2015-08-14 |
| Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. recall (Z-1064-2015) | Virtual Imaging, Inc. | 2015-02-09 |