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SEDECAL SA

FDA Regulatory Profile

Summary

Total Recalls
57
510(k) Clearances
26
Inspections
3
Compliance Actions
0

Known Names

sedecal, sedecal usa

Recent Recalls

NumberClassProductDate
Z-0250-2026Class IIModel Number 40KWFXPLUS.889, Mobile X-ray systemJune 10, 2025
Z-0262-2026Class IISedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemJune 10, 2025
Z-0270-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemJune 10, 2025
Z-0272-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemJune 10, 2025
Z-0271-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemJune 10, 2025
Z-0278-2026Class IIModel Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemJune 10, 2025
Z-0269-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemJune 10, 2025
Z-0248-2026Class IIModel Number 40KWFXPLUS.004, Mobile X-ray systemJune 10, 2025
Z-0264-2026Class IIModel Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemJune 10, 2025
Z-0256-2026Class IIModel SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemJune 10, 2025
Z-0261-2026Class IIModel Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemJune 10, 2025
Z-0273-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemJune 10, 2025
Z-0275-2026Class IIModel Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray systemJune 10, 2025
Z-0274-2026Class IIModel Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemJune 10, 2025
Z-0282-2026Class IISED URS LP, Mobile X-ray systemJune 10, 2025
Z-0266-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemJune 10, 2025
Z-0287-2026Class IISM_40HF_BDC3, Mobile X-ray systemJune 10, 2025
Z-0244-2026Class IIModel Number 40KWFX, Mobile X-ray systemJune 10, 2025
Z-0259-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemJune 10, 2025
Z-0263-2026Class IIModel Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemJune 10, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K232185SM-IVAugust 21, 2023
K222951SM-VNovember 21, 2022
K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.July 18, 2022
K212291PHOENIXSeptember 14, 2021
K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsFebruary 1, 2021
K202293Radiographic System Challenge XOctober 7, 2020
K192936Soltus 500November 15, 2019
K192011PhoeniXSeptember 25, 2019
K191813MobileDiagnost wDR 2.2August 2, 2019
K173299DRAGON X SPSL4HC, DRAGON X SPSL8HCJanuary 26, 2018
K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRJuly 6, 2016
K141895MOBILEDIAGNOST WDRSeptember 18, 2014
K133782NOVA FA DR SYSTEMMarch 21, 2014
K130883SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-TApril 18, 2013
K121410DRAGON LWAugust 2, 2012
K101517SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAYAugust 5, 2011
K111725MOBILEDIAGNOST WDRJuly 19, 2011
K103522SEDECALJanuary 26, 2011
K090322EASY MOVING PLUS, SM-XXHF-YYMarch 17, 2009
K090279SEDECAL, MILLENNIUM PLUSMarch 11, 2009