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
DEN180005Unknown

OsteoDetect

Imagen Technologies, Inc., New York NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN180005 is the FDA 510(k) clearance record for OsteoDetect, a class II device, cleared for Imagen Technologies, Inc. on under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture). FDA's definition for product code QBS 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...". FDA records list 6 510(k) clearances for Imagen Technologies, Inc., from to . As of , FDA records show no recalls naming DEN180005.

Clearance record

Decision date
Received
(108 days to decision)
Product code
QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Regulation
21 CFR 892.2090
Device class
Class II
Review panel
Radiology
Applicant
Imagen Technologies, Inc. 33 E. 33rd St., Suite 506, New York NY
Third party review
No

Clearances, product code QBS

Trailing 12 months
2 clearances under product code QBS in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QBS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260