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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) K232617 ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemIYN2023-09-26 View
510(k) K223812 Sensis Vibe (VD15)DQK2023-09-15 View
510(k) K232482 MAGNETOM Viato.MobileLNH2023-09-06 View
510(k) K231833 Biograph Vision.X and Biograph Vision.X EdgeKPS2023-07-13 View
510(k) K230421 SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition FlashJAK2023-06-16 View
510(k) K231102 Symbia Pro.specta VA20A FamilyKPS2023-05-17 View
510(k) K223343 MAGNETOM Amira; MAGNETOM SempraLNH2023-03-28 View
510(k) K213805 MAGNETOM VidaLNH2023-02-24 View
510(k) K230207 ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2023-02-13 View
510(k) K223735 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound SystemIYN2023-02-06 View
510(k) K223363 MAMMOVISTA B.smart (VB70)LLZ2023-01-12 View
510(k) K223547 Biograph Vision Quadra PET/CT SystemKPS2022-12-22 View
510(k) K223410 Cios Select (VA21) Flat PanelOWB2022-12-07 View
510(k) K223409 Cios Select (VA21) Image IntensifierOWB2022-12-06 View
510(k) K222428 Syngo Dynamics (Version VA40F)QIH2022-11-14 View
510(k) K222361 AI-Rad Companion (Musculoskeletal)JAK2022-10-20 View
510(k) K221305 AI-Rad Companion Organs RTQKB2022-10-14 View
510(k) K221733 MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitLNH2022-09-13 View
510(k) K220783 syngo.via RT Image SuiteMUJ2022-09-07 View
510(k) K222172 MI View&GOQIH2022-08-19 View

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