58 results
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39ms
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Sources: EU EUDAMED, US FDA
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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 radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·August 26, 2015
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·February 11, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·March 16, 2016
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA Enforcement
Class II
·Ongoing·Sedecal S.A.·November 28, 2018
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Enforcement
Class II
·Terminated·Sedecal USA, Inc.·June 15, 2016
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
RADPRO MOBILE, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_BDC3, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025