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Siemens Medi Cal Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K193216syngo.CT Lung CADMarch 9, 2020
K182639MOBILETT Elara MaxMarch 15, 2019
K182517MULTIX ImpactJanuary 11, 2019
K181279Ysio MaxJune 13, 2018
K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxApril 2, 2018
K173408Mammomat RevelationMarch 21, 2018
K172832Insight BDFebruary 6, 2018
K171766Acuson SC2000 Diagnostic Ultrasound SystemJuly 12, 2017
K170315Acuson SC2000 Diagnostic Ultrasound SystemApril 4, 2017
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitNovember 22, 2016
K162417Acuson Freestyle Ultrasound SystemSeptember 28, 2016
K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSeptember 6, 2016
K153360ADMIREJune 29, 2016
K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitApril 15, 2016
K150493SensisJune 30, 2015
K143319Syngo X-workplace SW VD10February 24, 2015
K133643SYNGO, CT LIVER ANALYSISNovember 13, 2014
K142628Acuson SC2000 Diagnostic Ultrasound SystemOctober 10, 2014
K132934MULTIX SELECT DRApril 10, 2014
K132094CIOS ALPHAMarch 11, 2014