Siemens Medical Solutions USA, Inc.

67 AI-enabled medical devices from Siemens Medical Solutions USA, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-06-25K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.Radiology
2026-06-16K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
2026-04-29K254184syngo Application SoftwareSiemens Medical Solutions USA, Inc.Radiology
2026-03-20K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.Radiology
2026-02-10K254016MI View&GOSiemens Medical Solutions USA, Inc.Radiology
2025-08-20K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
2025-07-03K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.Radiology
2025-04-10K243145syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc.Radiology
2025-02-12K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.Radiology
2024-11-19K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
2024-09-23P140011/S008MAMMOMAT B.brilliant with Tomosynthesis OptionSIEMENS MEDICAL SOLUTIONS USA, INC.Radiology
2024-08-30K242300MI View&GOSiemens Medical Solutions USA, Inc.Radiology
2024-08-30K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.Radiology
2024-07-22K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions, USA, Inc.Radiology
2024-04-26K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.Radiology
2024-03-28K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.Radiology
2024-03-26K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.Radiology
2024-03-22K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.Radiology
2024-03-22K232431syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.Radiology
2024-02-29K232765MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc.Radiology
2024-01-12K233677Biograph VK10Siemens Medical Solutions USA, Inc.Radiology
2023-12-22K232535MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc.Radiology
2023-12-18K231587MAGNETOM Cima.XSiemens Medical Solutions USA, Inc.Radiology
2023-11-28K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.Radiology
2023-11-14K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc.Radiology
2023-11-09K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.Radiology
2023-10-30K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
2023-10-23K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc.Radiology
2023-09-06K232482MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.Radiology
2023-07-13K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.Radiology
2023-03-28K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA Inc.Radiology
2022-11-14K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.Radiology
2022-10-20K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.Radiology
2022-10-14K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, IncRadiology
2022-09-13K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc.Radiology
2022-09-07K220783syngo.via RT Image SuiteSiemens Medical Solutions USA Inc.Radiology
2022-08-19K222172MI View&GOSiemens Medical Solutions USA, Inc.Radiology
2022-07-13K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.Radiology
2022-06-24K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.Radiology
2022-05-17K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.Radiology
2022-05-13K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.Radiology
2022-04-29K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA Inc.Radiology
2022-04-01K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.Radiology
2022-02-25K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.Radiology
2022-01-28K203260syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.Radiology
2022-01-20K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.Radiology
2021-12-06K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.Radiology
2021-07-30K211379syngo.via RT Image SuiteSiemens Medical Solutions USA Inc.Radiology
2021-07-01K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.Radiology
2021-06-10K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.Radiology
2021-03-31K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.Radiology
2020-11-18K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.Radiology
2020-11-06K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.Radiology
2020-08-13K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.Radiology
2020-07-30K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA Inc.Radiology
2020-07-10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.Radiology
2020-06-17K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.Radiology
2020-05-14K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.Radiology
2020-03-16K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.Radiology
2020-02-14K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, IncRadiology
2019-12-17K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.Radiology
2019-09-18K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.Radiology
2019-09-10K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.Radiology
2019-07-26K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.Radiology
2019-02-01K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.Radiology
2017-06-09K170747syngo Application SoftwareSiemens Medical Solutions, USA, Inc.Radiology
2014-01-24K133259YSIO MAXSIEMENS MEDICAL SOLUTIONS USA, INC.Radiology

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