FDA Product Code QBS: Radiological Computer Assisted Detection/diagnosis Software For Fracture
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.
Leading manufacturers include Ge Medical Systems, LLC, Icometrix NV and Azmed Sas.
FDA 510(k) Cleared Radiological Computer Assisted Detection/diagnosis Software For Fracture Devices (Product Code QBS)
About Product Code QBS - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QBS since 2018, with 8 receiving FDA clearance (average review time: 180 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
FDA review times for QBS submissions have been consistent, averaging 175 days recently vs 183 days historically.
QBS devices are reviewed by the Radiology panel. Browse all Radiology devices →