510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QBSClass II

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

21 CFR 892.2090 / Radiology
FDA source (opens on fda.gov)

QBS is the FDA product code for Radiological Computer Assisted Detection/Diagnosis Software For Fracture, a class II device type, regulated under 21 CFR 892.2090. FDA's definition for this code reads: "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...". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBS
Device name
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
FDA definition
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.
Regulation
21 CFR 892.2090
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code QBS

By decision year
11 clearances under product code QBS with a decision year between 2018 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QBS by decision year
YearClearances
20181
20201
20222
20232
20242
20251
20262

Applicants with the most clearances

Product code QBS
Applicants holding the most 510(k) clearances under product code QBS
ApplicantClearances
Azmed SAS2
Gleamer2
Imagen Technologies, Inc.2
AZmed1
AZmed1
GE Healthcare1
icometrix1
Milvue1

Companies listing this code with FDA

Companies whose registered establishments list this code