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Subtle Medical, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories3
Latest FDA decision2026-05-15
TypeNumberDevice NameCodeDateActions
510(k) K254120 SubtleHD-CT (1.x)QIH2026-05-15 View
510(k) K254013 SubtleHD-PET (1.x)LLZ2026-05-14 View
510(k) K243250 SubtleHD (1.x)QIH2025-02-12 View
510(k) K240290 AiMIFY (1.x)LLZ2024-08-21 View
510(k) K241329 SubtleSYNTH (1.x)QIH2024-07-11 View
510(k) K233699 SubtleREFORMAT (1.x)LLZ2024-04-29 View
510(k) K223623 SubtleMR (2.3.x)LLZ2023-05-11 View
510(k) K211964 SubtlePETKPS2021-09-28 View
510(k) K203182 SubtleMRLLZ2021-02-26 View
510(k) K191688 SubtleMRLLZ2019-09-16 View
510(k) K182336 SubtlePETKPS2018-11-30 View
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