← FDA Medical Device Classifications
Chest X-Ray Computer Aided Detection
OMJ · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
- FDA Product Code
OMJ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.2050
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown