Definition: A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Lesions Is An Image Processing Device Intended To Aid In The Detection, Localization, And Characterization Of Lesions Suspicious For Cancer On Acquired Medical Images (e
| Device Type ID | 5427 |
| Device Name | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Physical State | Software Device That Receives Radiological Images As An Input And Provides The User With The Identification And Characterization Of Suspicious Lesions As An Output. |
| Technical Method | Analyzes Radiological Images Using Machine Learning Algorithms To Detect And Diagnose Lesions Suspicious For Cancer. |
| Target Area | Anatomical Sites That May Contain Lesions Suspicious For Cancer. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.2090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5427 |
| Device | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Product Code | QDQ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.2090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ICAD INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |