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Siemens Medical Solutions USA, Inc.

FDA 510(k) & PMA Approved Devices — 252 products

Total Devices252
Categories18
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K210262 Biograph Vision Quadra PET/CT SystemKPS2021-03-03 View
510(k) K210055 Cios AlphaOWB2021-02-05 View
510(k) K203726 ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ2021-01-19 View
510(k) K203345 MULTIX ImpactKPR2021-01-07 View
510(k) K203340 MULTIX Impact CKPR2021-01-06 View
510(k) K203504 Cios FlowOWB2020-12-22 View
510(k) K201195 syngo.via MI Workflows, syngo MBFQIH2020-11-18 View
510(k) K193562 AI-Rad Companion Organs RTQKB2020-11-06 View
510(k) K201670 YSIO X.preeKPR2020-10-21 View
510(k) K202683 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYN2020-10-15 View
510(k) K202213 syngo.CT Neuro PerfusionJAK2020-10-11 View
510(k) K202014 Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitLNH2020-09-08 View
510(k) K201444 Syngo.via RT Image SuiteMUJ2020-08-13 View
510(k) K193283 AI-Rad Companion Prostate MRQIH2020-07-30 View
510(k) K193277 SOMATOM On.site and On.sceneJAK2020-07-22 View
510(k) K193294 AI-Rad Companion EngineLLZ2020-07-10 View
510(k) K201462 ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-06-24 View
510(k) K193290 AI-Rad Companion Brain MRLLZ2020-06-17 View
510(k) K193166 MAMMOMAT RevelationMUE2020-06-12 View
510(k) K201202 MI View&GOLLZ2020-06-02 View

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