OMJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chest X-Ray Computer Aided Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA definition
- To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IQQA-CHEST SOFTWARE PACKAGE (K042408) | Edda Technology, Inc. | 2004-10-08 |
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