Chest X-Ray Computer Aided Detection
The Chest X-Ray Computer Aided Detection device (product code OMJ) is a Class 2 radiology device regulated under 21 CFR 892.2050 in the Radiology specialty (RA), cleared via 510(k). It is intended to assist radiologists in reviewing chest radiographic images by automatically highlighting potential pulmonary nodules that warrant further clinical review. The device is not an implant or life-sustaining and is reviewed by the Radiology panel.
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Basic Information
- Product Code
- OMJ
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042408 | IQQA-CHEST SOFTWARE PACKAGE | Oct 08, 2004 | Substantially Equivalent | Edda Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.