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FDA 510(k) Applications Submitted by SEDECAL SA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121410
05/11/2012
DRAGON LW
SEDECAL SA
K133782
12/12/2013
NOVA FA DR SYSTEM
SEDECAL SA
K111725
06/20/2011
MOBILEDIAGNOST WDR
SEDECAL SA
K141895
07/14/2014
MOBILEDIAGNOST WDR
SEDECAL SA
K130883
03/29/2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
SEDECAL SA
K212291
07/22/2021
PHOENIX
Sedecal SA
K222951
09/27/2022
SM-V
SEDECAL SA
K232185
07/24/2023
SM-IV
Sedecal SA
K221803
06/22/2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
SEDECAL SA
K203537
12/03/2020
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
SEDECAL SA
K161345
05/13/2016
RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
SEDECAL SA
K173299
10/17/2017
DRAGON X SPSL4HC, DRAGON X SPSL8HC
Sedecal SA
K191813
07/05/2019
MobileDiagnost wDR 2.2
Sedecal SA
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