510(k) K161345 · IZL System, X-Ray, Mobile
RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
| Applicant | Sedecal., Sa., Algete, ES |
| Decision | Substantially Equivalent, Jul 6, 2016 |
| Received | May 13, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFX, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KW-FX.899, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.002, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.004, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.005, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.889, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS-710CW, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA RADPRO MOBILE, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA SM_40HF_B_D_VIR3, Mobile X-ray system Open, Classified |
IZL | None listed |
| Oct 23, 2025 | SEDECAL SA SM_40HF_B_D_VIR3.004, Mobile X-ray system Open, Classified |
IZL | None listed |
| May 2, 2024 | SEDECAL SA Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers:
a. SM-20HF-Batt;
b. SM-32HF-Batt;
c. SM-40HF-Batt;
d. SM-50HF-Batt;
e. SM-40-HF-B-D-VIR;
f. SM-20HF-B-D-K Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.