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FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories6
Latest FDA decision2026-04-22
TypeNumberDevice NameCodeDateActions
510(k) K253163 EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)QAS2026-04-22 View
510(k) K251306 Seg Pro V3 (RT-300)QKB2026-01-28 View
510(k) K242821 EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)QAS2025-02-20 View
510(k) K241923 EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)QAS2024-12-06 View
510(k) K234042 EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)QIH2024-06-07 View
510(k) K240291 EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMQAS2024-04-08 View
510(k) K231025 EFAI NeuroSuite CT ICH Assessment SystemQAS2023-10-04 View
510(k) K231928 EFAI RTSUITE CT HCAP-Segmentation SystemQKB2023-09-25 View
510(k) K232100 Efai Pacs Picture Archiving and Communication System ProLLZ2023-08-08 View
510(k) K221552 EFAI ChestSuite XR Pneumothorax Assessment SystemQFM2022-11-08 View
510(k) K222076 EFAI ChestSuite XR Pleural Effusion Assessment SystemQFM2022-09-08 View
510(k) K213731 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsKPS2022-05-31 View
510(k) K220264 EFAI RTSuite CT HN-Segmentation SystemQKB2022-04-28 View
510(k) K212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemQIH2022-04-04 View
510(k) K211257 EFAI PACS Picture Archiving and Communication SystemLLZ2021-09-10 View
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