Chest X-ray Computer Aided Detection
Device Code: 5413
Product Code(s):
OMJ Definition: To Assist Radiologists In The Review Of Chest Radiographic Images And Highlight Potential Nodules That The Radiologist Should Review.
Device Classification Information
| Device Type ID | 5413 |
| Device Name | Chest X-ray Computer Aided Detection |
| Physical State | Software Device. |
| Technical Method | Detection Algorithm Searches For And Identifies Potential Nodules On Images Of The Chest Acquired Using X-ray. |
| Target Area | Chest |
| Regulation Description | Picture Archiving And Communications System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 892.2050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5413 |
| Device | Chest X-ray Computer Aided Detection |
| Product Code | OMJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Picture Archiving And Communications System. |
| CFR Regulation Number | 892.2050 [🔎] |
TPLC Last Update: 2019-04-02 21:05:47