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Siemens Medical Solutions USA, Inc.

782 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
syngo.CT Coronary Cockpit (K253786)Siemens Medical Solutions USA, Inc.2026-06-25
MAMMOMAT B.brilliant (11372950) (K253678)Siemens Medical Solutions USA, Inc.2026-06-18
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844)Siemens Medical Solutions USA, Inc.2026-06-16
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315)Siemens Medical Solutions USA, Inc.2026-05-21
syngo Application Software (K254184)Siemens Medical Solutions USA, Inc.2026-04-29
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173)Siemens Medical Solutions USA, Inc.2026-04-24
ARTIS genio floor; ARTIS icono.explore floor (K253752)Siemens Medical Solutions USA, Inc.2026-04-23
SOMATOM X.cite; SOMATOM X.ceed (K253574)Siemens Medical Solutions USA, Inc.2026-03-20
MI View&GO (K254016)Siemens Medical Solutions USA, Inc.2026-02-10
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System (K253487)Siemens Medical Solutions USA, Inc.2025-11-17
ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System (K253457)Siemens Medical Solutions USA, Inc.2025-11-13
Cios Select (K250241)Siemens Medical Solutions USA, Inc.2025-11-04
syngo.CT Dual Energy (K251805)Siemens Medical Solutions USA, Inc.2025-10-15
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K251481)Siemens Medical Solutions USA, Inc.2025-08-20
Biograph Trinion (K251561)Siemens Medical Solutions USA, Inc.2025-07-31
Cios Spin (K251523)Siemens Medical Solutions USA, Inc.2025-07-29
NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K251061)Siemens Medical Solutions USA, Inc.2025-07-28
Cios Alpha; Cios Flow (K251520)Siemens Medical Solutions USA, Inc.2025-07-09
syngo.via MI Workflows; Scenium; syngo MBF (K251528)Siemens Medical Solutions USA, Inc.2025-07-03
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (K251671)Siemens Medical Solutions USA, Inc.2025-07-03
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse (K250822)Siemens Medical Solutions USA, Inc.2025-07-03
syngo.CT LVO Detection (K243145)Siemens Medical Solutions USA, Inc.2025-04-10
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K243523)Siemens Medical Solutions USA, Inc.2025-02-12
syngo.CT Dual Energy (K241757)Siemens Medical Solutions USA, Inc.2025-01-03
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K242523)Siemens Medical Solutions USA, Inc.2024-11-19
ACUSON Redwood Diagnostic Ultrasound System (K243299)Siemens Medical Solutions USA, Inc.2024-11-15
Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (K243186)Siemens Medical Solutions USA, Inc.2024-10-30
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572)Siemens Medical Solutions USA, Inc.2024-10-22
syngo Application Software (K241569)Siemens Medical Solutions USA, Inc.2024-10-11
SOMATOM On.site (K241295)Siemens Medical Solutions USA, Inc.2024-09-03
syngo.via MI Workflows; Scenium; syngo MBF (K242275)Siemens Medical Solutions USA, Inc.2024-08-30
MI View&GO (K242300)Siemens Medical Solutions USA, Inc.2024-08-30
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704)Siemens Medical Solutions USA, Inc.2024-07-22
ACUSON SC2000 Diagnostic Ultrasound System (K233613)Siemens Medical Solutions USA, Inc.2024-06-12
ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System (K233610)Siemens Medical Solutions USA, Inc.2024-06-12
syngo.via RT Image Suite (K232799)Siemens Medical Solutions USA, Inc.2024-04-26
MAGNETOM Viato.Mobile (K240608)Siemens Medical Solutions USA, Inc.2024-03-29
NAEOTOM Alpha (K233657)Siemens Medical Solutions USA, Inc.2024-03-28
MAMMOMAT B.brilliant (K233539)Siemens Medical Solutions USA, Inc.2024-03-27
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed (K233650)Siemens Medical Solutions USA, Inc.2024-03-26
MAGNETOM Terra; MAGNETOM Terra.X (K232322)Siemens Medical Solutions USA, Inc.2024-03-22
syngo.CT Brain Hemorrhage (K232431)Siemens Medical Solutions USA, Inc.2024-03-22
CIARTIC Move (VB10) (K233748)Siemens Medical Solutions USA, Inc.2024-03-15
MAGNETOM Cima.X Fit (K232765)Siemens Medical Solutions USA, Inc.2024-02-29
Biograph VK10 (K233677)Siemens Medical Solutions USA, Inc.2024-01-12
syngo.CT Applications (K232136)Siemens Medical Solutions USA, Inc.2024-01-04
MAGNETOM Sola; MAGNETOM Altea (K232535)Siemens Medical Solutions USA, Inc.2023-12-22
syngo Application Software (K230955)Siemens Medical Solutions USA, Inc.2023-12-20
MAGNETOM Cima.X (K231587)Siemens Medical Solutions USA, Inc.2023-12-18
ARTIS pheno (VE30A) (K230949)Siemens Medical Solutions USA, Inc.2023-12-15
ARTIS icono (VE30A) (K230950)Siemens Medical Solutions USA, Inc.2023-12-14
SOMATOM Pro.Pulse (K232206)Siemens Medical Solutions USA, Inc.2023-12-06
syngo.CT Dual Energy (K232155)Siemens Medical Solutions USA, Inc.2023-11-30
syngo.via MI Workflows; Scenium; syngo MBF (K232000)Siemens Medical Solutions USA, Inc.2023-11-28
MAGNETOM Avanto fit; MAGNETOM Skyra fit (K232494)Siemens Medical Solutions USA, Inc.2023-11-14
MAGNETOM Free.Max; MAGNETOM Free.Star (K231617)Siemens Medical Solutions USA, Inc.2023-11-09
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System (K232145)Siemens Medical Solutions USA, Inc.2023-10-30
AcuNav Crystal Ultrasound Catheter (K233270)Siemens Medical Solutions USA, Inc.2023-10-28
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560)Siemens Medical Solutions USA, Inc.2023-10-23
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System (K232617)Siemens Medical Solutions USA, Inc.2023-09-26
Sensis Vibe (VD15) (K223812)Siemens Medical Solutions USA, Inc.2023-09-15
MAGNETOM Viato.Mobile (K232482)Siemens Medical Solutions USA, Inc.2023-09-06
Biograph Vision.X and Biograph Vision.X Edge (K231833)Siemens Medical Solutions USA, Inc.2023-07-13
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash (K230421)Siemens Medical Solutions USA, Inc.2023-06-16
Symbia Pro.specta VA20A Family (K231102)Siemens Medical Solutions USA, Inc.2023-05-17
MAGNETOM Amira; MAGNETOM Sempra (K223343)Siemens Medical Solutions USA, Inc.2023-03-28
MAGNETOM Vida (K213805)Siemens Medical Solutions USA, Inc.2023-02-24
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207)Siemens Medical Solutions USA, Inc.2023-02-13
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (K223735)Siemens Medical Solutions USA, Inc.2023-02-06
MAMMOVISTA B.smart (VB70) (K223363)Siemens Medical Solutions USA, Inc.2023-01-12
Biograph Vision Quadra PET/CT System (K223547)Siemens Medical Solutions USA, Inc.2022-12-22
Cios Select (VA21) Flat Panel (K223410)Siemens Medical Solutions USA, Inc.2022-12-07
Cios Select (VA21) Image Intensifier (K223409)Siemens Medical Solutions USA, Inc.2022-12-06
Syngo Dynamics (Version VA40F) (K222428)Siemens Medical Solutions USA, Inc.2022-11-14
AI-Rad Companion (Musculoskeletal) (K222361)Siemens Medical Solutions USA, Inc.2022-10-20
AI-Rad Companion Organs RT (K221305)Siemens Medical Solutions USA, Inc.2022-10-14
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit (K221733)Siemens Medical Solutions USA, Inc.2022-09-13
syngo.via RT Image Suite (K220783)Siemens Medical Solutions USA, Inc.2022-09-07
MI View&GO (K222172)Siemens Medical Solutions USA, Inc.2022-08-19
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System (K221190)Siemens Medical Solutions USA, Inc.2022-08-16
ARTIS icono (Ceiling Configuration) (K221516)Siemens Medical Solutions USA, Inc.2022-07-19
syngo.CT Extended Functionality (K221727)Siemens Medical Solutions USA, Inc.2022-07-13
NAEOTOM Alpha, Scan&GO Software (K220814)Siemens Medical Solutions USA, Inc.2022-07-12
ARTIS pheno (VE21) System (K220409)Siemens Medical Solutions USA, Inc.2022-06-29
ARTIS icono (VE21) System (K220432)Siemens Medical Solutions USA, Inc.2022-06-29
MAGNETOM Free.Max, MAGNETOM Free.Star (K220575)Siemens Medical Solutions USA, Inc.2022-06-24
ACUSON Sequoia Diagnostic Ultrasound System (K221500)Siemens Medical Solutions USA, Inc.2022-06-14
syngo Dynamics (Version VA40E) (K220832)Siemens Medical Solutions USA, Inc.2022-05-20
MULTIX Impact E (K220919)Siemens Medical Solutions USA, Inc.2022-05-17
syngo.CT CaScoring (K221219)Siemens Medical Solutions USA, Inc.2022-05-17
MAGNETOM Skyra Fit (K220589)Siemens Medical Solutions USA, Inc.2022-05-13
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A (K220939)Siemens Medical Solutions USA, Inc.2022-04-29
MAGNETOM Avanto Fit (K220151)Siemens Medical Solutions USA, Inc.2022-04-01
Syngo.CT Dual Energy (K212889)Siemens Medical Solutions USA, Inc.2022-03-28
MAGNETOM Vida, MAGNETOM Sola (K220425)Siemens Medical Solutions USA, Inc.2022-03-11
syngo.CT Applications (K220450)Siemens Medical Solutions USA, Inc.2022-03-07
MAGNETOM Vida with syngo MR XA50A (K213693)Siemens Medical Solutions USA, Inc.2022-02-25
ACUSON P500 Ultrasound System (K213487)Siemens Medical Solutions USA, Inc.2022-02-11
syngo.CT Brain Hemorrhage (K203260)Siemens Medical Solutions USA, Inc.2022-01-28
syngo.CT Extended Functionality (K214019)Siemens Medical Solutions USA, Inc.2022-01-20
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