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 Imagen Technologies, Inc., Gleamer and Azmed Sas.

10
Total
9
Cleared
172d
Avg days
2018
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 156d avg (recent)

FDA 510(k) Cleared Radiological Computer Assisted Detection/diagnosis Software For Fracture Devices (Product Code QBS)

10 devices
1–10 of 10
Cleared May 12, 2026
Rayvolve
K260378
AZmed
Radiology · 96d
Cleared Jan 17, 2025
TechCare Trauma
K242171
Milvue
Radiology · 177d
Cleared Nov 07, 2024
icobrain aria
K240712
Icometrix NV
Radiology · 237d
Cleared Jul 17, 2024
Rayvolve
K240845
Azmed Sas
Radiology · 112d
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
Cleared Mar 02, 2023
BoneView
K222176
Gleamer
Radiology · 223d
Cleared Jun 02, 2022
Rayvolve
K220164
Azmed Sas
Radiology · 133d
Cleared Mar 01, 2022
BoneView
K212365
Gleamer
Radiology · 214d
Cleared Jul 30, 2020
FractureDetect (FX)
K193417
Imagen Technologies, Inc.
Radiology · 234d
Not Cleared May 24, 2018
OsteoDetect
DEN180005
Imagen Technologies, Inc.
Radiology · 108d

About Product Code QBS - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code QBS since 2018, with 9 receiving FDA clearance (average review time: 172 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QBS Product Code

FDA review times for QBS submissions have been consistent, averaging 156 days recently vs 183 days historically.

QBS devices are reviewed by the Radiology panel. Browse all Radiology devices →