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Lunit, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2026-04-23
TypeNumberDevice NameCodeDateActions
510(k) K260320 Lunit INSIGHT MMG (v1.1.10)QDQ2026-04-23 View
510(k) K253796 Lunit INSIGHT DBT (V1.2)QDQ2026-03-26 View
510(k) K242652 Lunit INSIGHT DBT v1.1QDQ2024-10-04 View
510(k) K231470 Lunit INSIGHT DBTQDQ2023-11-06 View
510(k) K211678 Lunit INSIGHT MMGQDQ2021-11-17 View
510(k) K211733 Lunit INSIGHT CXR TriageQFM2021-11-10 View
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