Definition: To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Unde
| Device Type ID | 5404 |
| Device Name | Lung Computed Tomography System, Computer-aided Detection |
| Physical State | Software Device. |
| Technical Method | Detection Algorithm Searches For And Identifies Potential Nodules On Images Of The Chest Acquired Using Multi-slice Computed Tomography (msct). |
| Target Area | Lung |
| 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 | OEB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5404 |
| Device | Lung Computed Tomography System, Computer-aided Detection |
| Product Code | OEB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Picture Archiving And Communications System. |
| CFR Regulation Number | 892.2050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SIEMENS AG MEDICAL SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |