Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA product code QBS · Class II (moderate risk) · 21 CFR 892.2090 · Radiology

A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.

10510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K261378Rayvolve AZchestQBS · Traditional AZmed08/28/2026SE
K260378RayvolveQBS · Traditional AZmed05/12/2026SE
K242171TechCare TraumaQBS · Traditional Milvue01/17/2025SE
K240712icobrain ariaQBS · Traditional Icometrix NV11/07/2024SE
K240845RayvolveQBS · Traditional Azmed Sas07/17/2024SE
K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1…QBS · Traditional Ge Medical Systems, LLC05/25/2023SE
K222176BoneViewQBS · Traditional Gleamer03/02/2023SE
K220164RayvolveQBS · Traditional Azmed Sas06/02/2022SE
K212365BoneViewQBS · Traditional Gleamer03/01/2022SE
K193417FractureDetect (FX)QBS · Traditional Imagen Technologies, Inc.07/30/2020SE