Product code OMJ
- Device name
- Chest X-Ray Computer Aided Detection
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
- Source
- FDA openFDA device classification dataset