Radiological Computer Assisted Detection/Diagnosis Software For Fracture
QBS · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2090
Classification
FDA Product Code
QBS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2090
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.