meddevicedb.com FDA Device Reference

OsteoDetect

DEN180005 Class II Direct
Decision Date
2018-05-24
Sponsor / Applicant
Imagen Technologies, Inc.

Technical Specification

510(k) Submission ID DEN180005
Product Code QBS
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2090
Decision Date 2018-05-24
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

OsteoDetect received FDA 510(k) clearance under submission number DEN180005, sponsored by Imagen Technologies, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-05-24.

Classification & Regulation

This clearance is catalogued under FDA product code QBS and 21 CFR 892.2090, within the Radiology review panel as a Class II device.