Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Siemens Medi Cal Solutions, Inc. · Predicate Candidate Screening

32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
204 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K193216syngo.CT Lung CADSiemens Medi Cal Solutions, Inc.2020-03-091090
K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.2019-03-151720
K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.2019-01-111200
K181279Ysio MaxSiemens Medi Cal Solutions, Inc.2018-06-13290
K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, MultiSiemens Medi Cal Solutions, Inc.2018-04-0212913
K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc.2018-03-211401
K172832Insight BDSiemens Medi Cal Solutions, Inc.2018-02-061400
K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017-07-12280
K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017-04-04621
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.2016-11-221161
K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.2016-09-28290
K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2016-09-06270
K153360ADMIRESiemens Medi Cal Solutions, Inc.2016-06-292220
K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM PriSiemens Medi Cal Solutions, Inc.2016-04-151481
K150493SensisSiemens Medi Cal Solutions, Inc.2015-06-301255
K143319Syngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc.2015-02-24972
K133643SYNGO, CT LIVER ANALYSISSiemens Medi Cal Solutions, Inc.2014-11-133510
K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2014-10-10240
K132934MULTIX SELECT DRSiemens Medi Cal Solutions, Inc.2014-04-102040
K132094CIOS ALPHASiemens Medi Cal Solutions, Inc.2014-03-112464
K131812SENSIS, SENSIS LITESiemens Medi Cal Solutions, Inc.2013-07-25360
K130754ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medi Cal Solutions, Inc.2013-03-2560
K121434SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/ASiemens Medi Cal Solutions, Inc.2012-11-051753
K112020SYNGO.CT VASCULAR ANALYSISSiemens Medi Cal Solutions, Inc.2011-08-18350
K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medi Cal Solutions, Inc.2009-12-01150
K090334ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medi Cal Solutions, Inc.2009-02-20100
K073003SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLYSiemens Medi Cal Solutions, Inc.2008-02-071060
K062454MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASESSiemens Medi Cal Solutions, Inc.2006-11-03730
K052423MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTIONSiemens Medi Cal Solutions, Inc.2006-01-131330
K04271813C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRASiemens Medi Cal Solutions, Inc.2004-11-12430
K042793ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION ISiemens Medi Cal Solutions, Inc.2004-10-29222
K041029KINETDXSiemens Medi Cal Solutions, Inc.2004-07-08781

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda