QBS · Class II · 21 CFR 892.2090

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.

1
Total
1
Cleared
185d
Avg days
2023
Since

List of Radiological Computer Assisted Detection/diagnosis Software For Fracture devices cleared through 510(k)

1 devices
1–1 of 1
Cleared May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
K223491
Ge Medical Systems, LLC
Radiology · 185d

How to use this database

This page lists all FDA 510(k) submissions for Radiological Computer Assisted Detection/diagnosis Software For Fracture devices (product code QBS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →