FDA product code OMJ: Chest X-Ray Computer Aided Detection
OMJ is the FDA product code for chest x-ray computer aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under OMJ. The average 510(k) review took 35 days (median 35).
Definition
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Classification
| Field | Value |
|---|---|
| Device name | Chest X-Ray Computer Aided Detection |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OMJ clearance
Top OMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edda Technology, Inc. | 1 | 2004-10-08 |
Most recent OMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042408 | Edda Technology, Inc. | IQQA-CHEST SOFTWARE PACKAGE | 2004-10-08 | 35 |
Recalls for OMJ devices
openFDA lists no recalls for product code OMJ.
Frequently asked questions
What is FDA product code OMJ?
OMJ is the FDA product code for chest x-ray computer aided detection. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is OMJ?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMJ?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most OMJ clearances?
Edda Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMJ
- Run a recall and safety report across every OMJ manufacturer
- Watch product code OMJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times