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67 devices · 5 companies · 2014 to 2026

Siemens Medical Solutions USA, Inc.: AI-enabled devices on FDA's list

67 devices from Siemens Medical Solutions USA, Inc., 2014 to 2026, from 5 companies across 11 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (63 of 67 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Siemens Medical Solutions USA, Inc.

Every device, newest decision first

Siemens Medical Solutions USA, Inc. · 67 devices
DecisionDevicePanelProduct codeFDA
syngo.CT Coronary CockpitK253786 · 510(k)RadiologyQIHdatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK260844 · 510(k)RadiologyIYNdatabase entry
syngo Application SoftwareK254184 · 510(k)RadiologyQIHdatabase entry
SOMATOM X.citeK253574 · 510(k)RadiologyJAKdatabase entry
MI View&GOK254016 · 510(k)RadiologyQIHdatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK251481 · 510(k)RadiologyIYNdatabase entry
syngo.via MI WorkflowsK251528 · 510(k)RadiologyQIHdatabase entry
syngo.CT LVO DetectionK243145 · 510(k)RadiologyQASdatabase entry
NAEOTOM Alpha.Peak/ NAEOTOM AlphaK243523 · 510(k)RadiologyJAKdatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK242523 · 510(k)RadiologyIYNdatabase entry
MAMMOMAT B.brilliant with Tomosynthesis OptionP140011/S008 · PMARadiologyOTEdatabase entry
MI View&GOK242300 · 510(k)RadiologyQIHdatabase entry
syngo.via MI WorkflowsK242275 · 510(k)RadiologyQIHdatabase entry
ACUSON Sequoia Diagnostic Ultrasound System, ACUK240704 · 510(k)RadiologyIYNdatabase entry
syngo.via RT Image SuiteK232799 · 510(k)RadiologyMUJdatabase entry
NAEOTOM AlphaK233657 · 510(k)RadiologyJAKdatabase entry
SOMATOM go.UpK233650 · 510(k)RadiologyJAKdatabase entry
MAGNETOM TerraK232322 · 510(k)RadiologyLNHdatabase entry
syngo.CT Brain HemorrhageK232431 · 510(k)RadiologyQASdatabase entry
MAGNETOM Cima.X FitK232765 · 510(k)RadiologyLNHdatabase entry
Biograph VK10K233677 · 510(k)RadiologyKPSdatabase entry
MAGNETOM SolaK232535 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Cima.XK231587 · 510(k)RadiologyLNHdatabase entry
syngo.via MI WorkflowsK232000 · 510(k)RadiologyQIHdatabase entry
MAGNETOM Avanto fitK232494 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Free.MaxK231617 · 510(k)RadiologyLNHdatabase entry
ACUSON Sequoia Diagnostic Ultrasound System, ACUK232145 · 510(k)RadiologyIYNdatabase entry
MAGNETOM VidaK231560 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Viato.MobileK232482 · 510(k)RadiologyLNHdatabase entry
Biograph Vision.X and Biograph Vision.X EdgeK231833 · 510(k)RadiologyKPSdatabase entry
MAGNETOM AmiraK223343 · 510(k)RadiologyLNHdatabase entry
Syngo DynamicsK222428 · 510(k)RadiologyQIHdatabase entry
AI-Rad CompanionK222361 · 510(k)RadiologyJAKdatabase entry
AI-Rad Companion Organs RTK221305 · 510(k)RadiologyQKBdatabase entry
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitK221733 · 510(k)RadiologyLNHdatabase entry
syngo.via RT Image SuiteK220783 · 510(k)RadiologyMUJdatabase entry
MI View&GOK222172 · 510(k)RadiologyQIHdatabase entry
syngo.CT Extended FunctionalityK221727 · 510(k)RadiologyJAKdatabase entry
MAGNETOM Free.Max, MAGNETOM Free.StarK220575 · 510(k)RadiologyLNHdatabase entry
syngo.CT CaScoringK221219 · 510(k)RadiologyJAKdatabase entry
MAGNETOM Skyra FitK220589 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Lumina and MAGNETOM Vida Fit with syngoK220939 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Avanto FitK220151 · 510(k)RadiologyLNHdatabase entry
MAGNETOM Vida with syngo MR XA50AK213693 · 510(k)RadiologyLNHdatabase entry
syngo.CT Brain HemorrhageK203260 · 510(k)RadiologyQASdatabase entry
syngo.CT Extended FunctionalityK214019 · 510(k)RadiologyJAKdatabase entry
Al-Rad CompanionK213096 · 510(k)RadiologyJAKdatabase entry
syngo.via RT Image SuiteK211379 · 510(k)RadiologyMUJdatabase entry
MAGNETOM Free.MaxK210611 · 510(k)RadiologyLNHdatabase entry
syngo.via MI WorkFlows, Scenium, syngo MBFK211459 · 510(k)RadiologyQIHdatabase entry
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MK203443 · 510(k)RadiologyLNHdatabase entry
syngo.via MI Workflows, syngo MBFK201195 · 510(k)RadiologyQIHdatabase entry
AI-Rad Companion Organs RTK193562 · 510(k)RadiologyQKBdatabase entry
Syngo.via RT Image SuiteK201444 · 510(k)RadiologyMUJdatabase entry
AI-Rad Companion Prostate MRK193283 · 510(k)RadiologyQIHdatabase entry
AI-Rad Companion EngineK193294 · 510(k)RadiologyLLZdatabase entry
AI-Rad Companion Brain MRK193290 · 510(k)RadiologyLLZdatabase entry
Syngo.CT CaScoringK201034 · 510(k)RadiologyJAKdatabase entry
Al-Rad CompanionK193267 · 510(k)RadiologyJAKdatabase entry
Biograph Vision, Biograph mCT Family of PET/CTsK193248 · 510(k)RadiologyKPSdatabase entry
syngo.CT CaScoringK192763 · 510(k)RadiologyJAKdatabase entry
Syngo.Via RT Image SuiteK192065 · 510(k)RadiologyMUJdatabase entry
AI-Rad CompanionK183268 · 510(k)RadiologyJAKdatabase entry
AI-Rad CompanionK183271 · 510(k)RadiologyJAKdatabase entry
AI Rad CompanionK183272 · 510(k)RadiologyLLZdatabase entry
syngo Application SoftwareK170747 · 510(k)RadiologyLLZdatabase entry
YSIO MAXK133259 · 510(k)RadiologyKPRdatabase entry

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