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Terarecon,Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest FDA decision2025-10-23
TypeNumberDevice NameCodeDateActions
510(k) K250288 TeraRecon Cardiovascular.Calcification.CTQIH2025-10-23 View
510(k) K243158 TeraRecon Aorta.CT (1.1.0)QIH2025-01-23 View
510(k) K241312 TeraRecon Cardiac.Chambers.MR (1.0.0)QIH2024-11-05 View
510(k) K220349 TeraRecon NeuroLLZ2022-08-12 View
510(k) K200750 Neuro.Al AlgorithmLLZ2020-11-06 View
510(k) K191585 iNtuition-Structural Heart ModuleLLZ2019-07-12 View
510(k) K180916 iNtuition-T1 Mapping and T2/T2* MappingLLZ2018-09-24 View
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