Company · US
SEDECAL SA
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2023. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
62recalls (0 in 12 months)
61recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2023 | K232185 | SM-IV Sedecal., Sa., ES | IZL |
| Nov 21, 2022 | K222951 | SM-V Sedecal., Sa., ES | IZL |
| Jul 18, 2022 | K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. Sedecal., Sa., ES | IZL |
| Sep 14, 2021 | K212291 | PHOENIX Sedecal., Sa., ES | IZL |
| Feb 1, 2021 | K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems Sedecal., Sa., ES | KPR |
| Oct 7, 2020 | K202293 | Radiographic System Challenge X Sedecal., Sa., ES | KPR |
| Nov 15, 2019 | K192936 | Soltus 500 Sedecal., Sa., ES | IZL |
| Sep 25, 2019 | K192011 | PhoeniX Sedecal., Sa., ES | IZL |
| Aug 2, 2019 | K191813 | MobileDiagnost wDR 2.2 Sedecal., Sa., ES | IZL |
| Jan 26, 2018 | K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC Sedecal., Sa., ES | IZL |
| Jul 6, 2016 | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Sedecal., Sa., ES | IZL |
| Sep 18, 2014 | K141895 | MOBILEDIAGNOST WDR Sedecal., Sa. | IZL |
| Mar 21, 2014 | K133782 | NOVA FA DR SYSTEM Sedecal., Sa. | MQB |
| Apr 18, 2013 | K130883 | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T Sedecal., Sa., ES | MQB |
| Aug 2, 2012 | K121410 | DRAGON LW Sedecal., Sa. | IZL |
| Aug 5, 2011 | K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa. | IZL |
| Jul 19, 2011 | K111725 | MOBILEDIAGNOST WDR Sedecal., Sa. | IZL |
| Jan 26, 2011 | K103522 | SEDECAL Sedecal., Sa. | IZL |
| Mar 17, 2009 | K090322 | EASY MOVING PLUS, SM-XXHF-YY Sedecal., Sa. | IZL |
| Mar 11, 2009 | K090279 | SEDECAL, MILLENNIUM PLUS Sedecal., Sa. | KPR |
| Feb 27, 2009 | K090238 | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS Sedecal., Sa. | KPR |
| Nov 17, 2006 | K063283 | DEFINIUM 5000 X-RAY SYSTEM Sedecal., Sa. | MQB |
| Sep 14, 2006 | K062335 | SEDECAL X PLUS LP PLUS Sedecal., Sa. | KPR |
| Nov 18, 2004 | K043002 | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR Sedecal., Sa. | IZL |
| Nov 18, 2004 | K042876 | URS LP DIGITAL, MILLENNIUM, RADPRO Sedecal., Sa. | KPR |
| Sep 29, 2004 | K042361 | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D Sedecal USA, Inc. | IZL |
| Feb 22, 2002 | K020436 | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 Sedecal., Sa. | IZL |
| Nov 2, 2001 | K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM Sedecal USA, Inc. | KPR |
| Aug 31, 2001 | K012663 | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) Sedecal USA, Inc. | IZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | SEDECAL SA SM_40HF_BDC3, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA SM_40HF_BDC, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA SM_40HF_B_D_VIR3.004, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA SM_40HF_B_D_VIR3, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA SHIMADZU RF.004, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA SED URS LP, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA RADPRO MOBILE, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system Open, Classified |
IZL | K191813 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWMOBILE3.899, Mobile X-ray system Open, Classified |
IZL | K090322 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS-710CW, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.889, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.005, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.004, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS.002, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFXPLUS, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KW-FX.899, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA Model Number 40KWFX, Mobile X-ray system Open, Classified |
IZL | K161345 |
| Oct 23, 2025 | SEDECAL SA MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Open, Classified |
IZL | K111725 K141895 +1 |
| Oct 23, 2025 | SEDECAL SA Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) Open, Classified |
IZL | K101517 |
| 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 | K161345 |
| Feb 14, 2024 | SEDECAL SA MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 Open, Classified |
IZL | K111725 K141895 +1 |
| Jan 23, 2024 | SEDECAL SA Sedecal X Optima URS digital mobile diagnostic x-ray system.
A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying posi Open, Classified |
KPR | K012546 |
| Jun 30, 2023 | SEDECAL SA wDR 2.2 Mobile Digital Diagnostic X-Ray System Open, Classified |
IZL | K191813 |
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