OsteoDetect
De Novo DEN180005
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN180005 | Date24 May 2018 | StatusActive |
Official records
- FDA De Novo database DEN180005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA product code
- QBS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2090
- Advisory committee
- Radiology
- FDA decision
- DENG De Novo granted
Overview
AI-generated summary, 10 Nov 2026
OsteoDetect is a radiological computer assisted detection/diagnosis software for fracture, as listed by the FDA under the product name Radiological Computer Assisted Detection/Diagnosis Software For Fracture. It was authorized under the De Novo grant DEN180005, which was decided on 2018-05-24.
Similar devices
Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).