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Automated Radiological Image Processing Software
FDA product code QIH · Class 2 · Radiology
442
Registered devices
10
Adverse events
2
Recalls
337
510(k) clearances
Devices with this code
AmCAD UT Detection — AMCAD BIOMED CORPORATIONHERA Z20 — SAMSUNG MEDISON CO., LTD.AVIEW — CORELINE SOFT CO.,LTD.LumiNE US — AugmedIT B.V.AI-Rad Companion Brain MR — Siemens Healthcare GmbHTOMTEC ARENA — Philips Ultrasound LLCFEops — FEopsArterys MICA — Arterys Inc.ADAS 3D — ADAS3D MEDICAL S.L.ACUSON Origin ICE Diagnostic Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.inHEART MODELS AI — INHEARTFEops — FEopsCA2-13M — SAMSUNG MEDISON CO., LTD.QP-Brain® — QUIBIM SOCIEDAD LIMITADA.Caption AI (Caption Guidance + Caption Interpretation) — CAPTION HEALTH, INC.Hermia — Hermes Medical Solutions ABSpine Auto Views — GE MEDICAL SYSTEMSOEC — GE Hualun Medical Systems Co., LtdEdgeFlow UH10 — EdgeCare Inc.EPIQ 7W Ultrasound System — Philips Ultrasound LLCcmAngio — Curemetrix, Inc.AutoContour — Radformation, IncEPIQ 5W Ultrasound System — Philips Ultrasound LLCFEops — FEops
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated eject |
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