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Brainomix Limited

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories5
Latest FDA decision2026-06-12
TypeNumberDevice NameCodeDateActions
510(k) K260406 Brainomix 360 HyperdensityQIH2026-06-12 View
510(k) K251983 Brainomix 360 Triage StrokeQAS2025-08-26 View
510(k) K242411 Brainomix 360 e-LungJAK2025-02-19 View
510(k) K243294 Brainomix 360 e-ASPECTSPOK2025-02-14 View
510(k) K242123 Brainomix 360 e-CTALLZ2025-01-06 View
510(k) K233875 Brainomix 360 e-LungJAK2024-05-13 View
510(k) K232496 Brainomix 360 Triage StrokeQAS2023-11-21 View
510(k) K231837 Brainomix 360 Triage LVOQAS2023-09-28 View
510(k) K231656 Brainomix 360 e-MRILLZ2023-08-30 View
510(k) K231195 Brainomix 360 Triage ICHQAS2023-07-27 View
510(k) K223555 Brainomix 360 e-CTPLLZ2023-06-01 View
510(k) K221564 Brainomix 360 e-ASPECTSPOK2023-02-23 View
510(k) K192692 Brainomix 360 e-CTALLZ2020-05-28 View
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