QBS — Radiological Computer Assisted Detection/Diagnosis Software For Fracture Class II

FDA Device Classification

Classification Details

Product Code
QBS
Device Class
Class II
Regulation Number
892.2090
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242171milvueTechCare TraumaJanuary 17, 2025
K240712icometrixicobrain ariaNovember 7, 2024
K240845azmedRayvolveJuly 17, 2024
K223491ge medical systemsCritical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care SuitMay 25, 2023
K222176gleamerBoneViewMarch 2, 2023
K220164azmedRayvolveJune 2, 2022
K212365gleamerBoneViewMarch 1, 2022
K193417imagen technologiesFractureDetect (FX)July 30, 2020
DEN180005imagen technologiesOsteoDetectMay 24, 2018