Devices · Imagen Technologies, Inc.

OsteoDetect

Imagen Technologies, Inc. is listed for OsteoDetect (DEN180005). The FDA list gives May 24, 2018 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QBS as “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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180005

Official FDA database record

Date of final decision

May 24, 2018

Company on the FDA list

Imagen Technologies, Inc.

Lead panel

Radiology

Primary product code

QBS

openFDA device name for the code

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Device class

2

Regulation number

892.2090

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned