Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2026, with 794 FDA device recalls on record.
Clearances by Siemens Medical Solutions USA, Inc. — page 3
201–300 of 784- K173625 — syngo.CT Clinical Extensions
- K173592 — MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
- K180067 — ACUSON X800 Diagnostic Ultrasound System
- K173957 — ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
- K180039 — ACUSON P600 Diagnostic Ultrasound System
- K173635 — syngo.via RT Image Suite
- K173578 — Biograph mCT Family of PET/CT Systems
- K173600 — MAGNETOM Amira
- K173618 — ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
- K173023 — Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
- K172531 — Biograph mMR with mMR Angio Transfer Option
- K170840 — MAGNETOM Terra
- K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
- K170263 — AcuNav Diagnostic Ultrasound Catheter 8F,10F
- K170992 — AcuNav V 10F Ultrasound Catheter
- K170396 — MAGNETOM Vida
- K170747 — syngo Application Software
- K170904 — Biograph Horizon PET/CT
- K170952 — syngo.CT View&GO
- K163297 — Scan&GO
- K163296 — SOMATOM go.Up, SOMATOM go.Now
- K163284 — syngo. CT Neuro Perfusion
- K163234 — Biograph mMR with syngo MR E11P system software
- K163341 — syngo.CT Extended Functionality
- K163478 — AcuNav Volume ICE Catheter
- K163294 — syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
- K163211 — MAGNETOM Sempra with syngo MR E11S
- K163312 — MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
- K163252 — Mammomat Fusion with Stereotactic Biopsy
- K162483 — Symbia Intevo Bold
- K163396 — ACUSON P500 Ultrasound System
- K163421 — syngo.via MI Workflows
- K162302 — Somatom Confidence ® RT Pro
- K162971 — Multix Fusion Max
- K161795 — MAGNETOM ESSENZA
- K162541 — syngo Application Software
- K162370 — syngo.via RT Image Suite
- K162736 — Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
- K162339 — Scenium
- K162337 — Symbia 6.5
- K161196 — SOMATOM Drive
- K161787 — ACUSON NX2 Diagnostic Ultrasound Systems
- K153447 — MAGNETOM Spectra
- K151765 — SOMATOM Perspective
- K151749 — somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
- K153244 — Cios Fusion
- K153346 — syngo Application Software VD11
- K160426 — syngo.via MI Workflows
- K160317 — syngo.via MI Workflows
- K153220 — syngo.CT Single Source Dual Energy (Twin Beam)
- K153232 — Cios Select
- K152880 — Biograph Horizon PET/CT
- K153147 — Cios Connect
- K152283 — MAGNETOM Amira
- K142955 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
- K152928 — Multitom Rax
- K151752 — SOMATOM Emotion 6/16
- K150713 — syngo.CT Myocardial Perfusion
- K152036 — SOMATOM Definition Edge, SOMATOM Definition AS/AS+
- K151579 — MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
- K151887 — syngo VSim
- K151645 — MAMMOMAT Fusion
- K151380 — syngo.via RT Image Suite
- K150745 — syngo.CT Single Source Dual Energy
- K150757 — syngo.CT Dual Energy
- K151353 — syngo.MR Neurology, syngo.MR Oncology
- K151486 — Biograph mCT and mCT Flow PET/CT Scanners
- K151192 — syngo.via MI Workflows
- K150785 — syngo.CT Dental
- K143416 — SOMATOM Definition Flash (VA48)
- K143400 — SOMATOM Definition AS/AS+
- K143401 — SOMATOM Definition Edge
- K150192 — Scenium
- K143409 — SOMATOM Definition AS Open (VA48)
- K150050 — ACUSON P500 Diagnostic Ultrasound System
- K142584 — iMAR
- K142049 — MULTIX FUSION VA30 & VA40
- K143254 — eSie Apps Suite
- K140920 — SYNGO.CT COLONOGRAPHY
- K142434 — ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
- K141977 — MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
- K142876 — ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
- K133677 — SYNGO CT SINGLE SOURCE DUAL ENERGY
- K142515 — MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
- K140912 — SOMATOM SCOPE/SOMATOM SCOPE POWER
- K141971 — BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
- K142395 — SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
- K141574 — ARTIS ZEE/ZEEGO SW VC21
- K142006 — SYMBIA 6.0
- K140232 — SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
- K141846 — ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
- K140897 — SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
- K141554 — ESIE APPS SUITE
- K133648 — SYNGO, CT DUAL ENERGY
- K133590 — SOMATOM PERSPECTIVE
- K140959 — ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
- K133580 — ARTIS ONE
- K133589 — SOMATOM FORCE
- K132902 — SYNGO DUAL ENERGY SOFTWARE PACKAGE
- K140253 — MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.