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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
PMA P140011 Digital breast tomosynthesisOTE2026-07-01 View
510(k) K253786 syngo.CT Coronary CockpitQIH2026-06-25 View
510(k) K253678 MAMMOMAT B.brilliant (11372950)MUE2026-06-18 View
510(k) K260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2026-06-16 View
510(k) K261315 Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilyKPS2026-05-21 View
510(k) K254184 syngo Application SoftwareQIH2026-04-29 View
510(k) K254173 ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB2026-04-24 View
510(k) K253752 ARTIS genio floor; ARTIS icono.explore floorOWB2026-04-23 View
510(k) K253574 SOMATOM X.cite; SOMATOM X.ceedJAK2026-03-20 View
510(k) K254016 MI View&GOQIH2026-02-10 View
510(k) K253487 ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemIYN2025-11-17 View
510(k) K253457 ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2025-11-13 View
510(k) K250241 Cios SelectOWB2025-11-04 View
510(k) K251805 syngo.CT Dual EnergyJAK2025-10-15 View
510(k) K251481 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2025-08-20 View
510(k) K251561 Biograph TrinionKPS2025-07-31 View
510(k) K251523 Cios SpinOWB2025-07-29 View
510(k) K251061 NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK2025-07-28 View
510(k) K251520 Cios Alpha; Cios FlowOWB2025-07-09 View
510(k) K251671 Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsKPS2025-07-03 View

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