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FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2023-08-21
TypeNumberDevice NameCodeDateActions
510(k) K232185 SM-IVIZL2023-08-21 View
510(k) K222951 SM-VIZL2022-11-21 View
510(k) K221803 PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.IZL2022-07-18 View
510(k) K212291 PHOENIXIZL2021-09-14 View
510(k) K203537 Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsKPR2021-02-01 View
510(k) K202293 Radiographic System Challenge XKPR2020-10-07 View
510(k) K192936 Soltus 500IZL2019-11-15 View
510(k) K192011 PhoeniXIZL2019-09-25 View
510(k) K191813 MobileDiagnost wDR 2.2IZL2019-08-02 View
510(k) K173299 DRAGON X SPSL4HC, DRAGON X SPSL8HCIZL2018-01-26 View
510(k) K161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRIZL2016-07-06 View