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Siemens Healthineers AG

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2026-07-31
TypeNumberDevice NameCodeDateActions
510(k) K260852 MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH2026-07-31 View
510(k) K253690 LungMapsQIH2026-06-15 View
510(k) K253023 BIOGRAPH OneOUO2026-01-15 View
510(k) K253495 syngo.MR Applications (VB80)LLZ2025-11-20 View
510(k) K251059 Syngo Carbon Clinicals (VA41)QIH2025-10-24 View
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