Home › Device types › QIH
Automated Radiological Image Processing Software
FDA product code QIH · Class 2 · Radiology
392
Registered devices
10
Adverse events
2
Recalls
320
510(k) clearances
Devices with this code
Syngo Carbon Clinicals — Siemens Healthcare GmbHNeosoma Dashboard — Neosoma, Inc.EPIQ 7 Diamond Select Ultrasound System — Philips Ultrasound LLCqER-Quant — QURE.AI TECHNOLOGIES PRIVATE LIMITEDLA2-9Sn — SAMSUNG MEDISON CO., LTD.OrthoNext™ Platform System Software — ORTHOFIX SRLEA2-11ARn — SAMSUNG MEDISON CO., LTD.Kosmos Link — ECHONOUS, INC.AiORTA - Plan — Vitaa Medical Solutions Inc.VUNO Med-DeepBrain — VUNO Inc.Affiniti 30 Diagnostic Ultrasound System — Philips Ultrasound LLCAffiniti 50 Diagnostic Ultrasound System — Philips Ultrasound LLCKosmos OTS iOS — ECHONOUS, INC.EPIQ 7C Diagnostic Ultrasound System Circular Edition — Philips Ultrasound LLCLOGIQ — GE Ultrasound Korea Ltd.Affiniti 50 Ultrasound Circular Edition — Philips Ultrasound LLCVELYS Trauma — metamorphosis GmbHQLAB Advanced Quantification Software — Philips Ultrasound LLCEPIQ CVx Diagnostic Ultrasound System — Philips Ultrasound LLCbrAIn Shoulder Positioning — AVATAR MEDICALMPXA — MedipixelEzra Flash — Ezra Ai, Inc.Spectral Bone Marrow — GE Medical Systems, L.L.C.PA1-5A — SAMSUNG MEDISON CO., LTD.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.