OMJ — Chest X-Ray Computer Aided Detection Class II
FDA product code OMJ covers "Chest X-Ray Computer Aided Detection", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OMJ
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042408 | edda technology | IQQA-CHEST SOFTWARE PACKAGE | October 8, 2004 |