510(k) K101517 ยท IZL System, X-Ray, Mobile
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
| Applicant | Sedecal., Sa., Naples FL, US |
| Decision | Substantially Equivalent, Aug 5, 2011 |
| Received | Jun 2, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | SEDECAL SA Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) Open, Classified |
IZL | None listed |
| Nov 2, 2018 | Virtual Imaging, Inc. RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C
Product Usage:
Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremiti Terminated |
MQB | None listed |
| Aug 14, 2015 | Sedecal S.A. RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray.
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiograp Terminated |
IZL | None listed |
| Feb 9, 2015 | Virtual Imaging, Inc. Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.