Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Code: 5424
Product Code(s):
POK Definition: Assist Users In Characterizing Lesions Identified On Acquired Medical Images
Device Classification Information
| Device Type ID | 5424 |
| Device Name | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Physical State | Software |
| Technical Method | The Device Characterizes Lesions Based On Features Or Information Extracted From The Images And Provides Information About The Lesion(s) To The User. |
| Target Area | Lesions |
| 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 | 892.2060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5424 |
| Device | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Product Code | POK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.2060 [🔎] |
TPLC Last Update: 2019-04-02 21:06:02