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.
12
Total
11
Cleared
164d
Avg days
2018
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg
130d
recently vs 181d historically
FDA 510(k) Cleared Radiological Computer Assisted Detection/diagnosis Software For Fracture Devices (Product Code QBS)
12 devices
Cleared
Oct 20, 2026
CINA-Aneurysm
Avicenna.Ai
Radiology
124d
Cleared
Aug 28, 2026
Rayvolve AZchest
AZmed
Radiology
123d
Cleared
May 12, 2026
Rayvolve
AZmed
Radiology
96d
Cleared
Jan 17, 2025
TechCare Trauma
Milvue
Radiology
177d
Cleared
Nov 07, 2024
icobrain aria
Icometrix NV
Radiology
237d
Cleared
Jul 17, 2024
Rayvolve
Azmed Sas
Radiology
112d
Cleared
May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
Ge Medical Systems, LLC
Radiology
185d
Cleared
Mar 02, 2023
BoneView
Gleamer
Radiology
223d
Cleared
Jun 02, 2022
Rayvolve
Azmed Sas
Radiology
133d
Cleared
Mar 01, 2022
BoneView
Gleamer
Radiology
214d
Cleared
Jul 30, 2020
FractureDetect (FX)
Imagen Technologies, Inc.
Radiology
234d
Not Cleared
May 24, 2018
OsteoDetect
Imagen Technologies, Inc.
Radiology
108d
About Product Code QBS - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code QBS since 2018, with 11 receiving FDA clearance (average review time: 164 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA 510(k) Review Time - QBS Product Code
Recent submissions under QBS have taken an average of 130 days to reach a decision - down from 181 days historically, suggesting improved FDA processing for this classification.
QBS devices are reviewed by the Radiology panel. Browse all Radiology devices →