Radiology · De Novo · 2018
OsteoDetect
Imagen Technologies, Inc.. Granted by FDA on 24 May 2018 under submission DEN180005, product code QBS (radiological computer assisted detection/diagnosis software for fracture). What FDA's record says, in FDA's words.
Device record · DEN180005
- Device. OsteoDetectDEVICE
- Company. Imagen Technologies, Inc.COMPANY
- Decision. 24 May 2018, De NovoDECISION
- Panel. RadiologyPANEL
- Product code. QBS, Radiological Computer Assisted Detection/Diagnosis Software For FractureCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (25 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
OsteoDetect analyzes wrist radiographs using machine learning techniques to identify 1 and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QBS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QBS, in Radiology, from Imagen Technologies, Inc., or granted in 2018. The whole record is at FDA AI-enabled medical devices.
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