Radiological Computer-assisted Prioritization Software For Lesions
Device Code: 5428
Product Code(s):
QFM Definition: Radiological Computer-assisted Prioritization Software For Lesions Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radi
Device Classification Information
| Device Type ID | 5428 |
| Device Name | Radiological Computer-assisted Prioritization Software For Lesions |
| Physical State | The Device Is Software Only. |
| Technical Method | The Device Provides Triage Or Notification That Is Informed By Machine Learning, Artificial Intelligence Or Other Image Analysis Algorithms.This Type Of Device Establishes Effective Triage Within A Specialists Queue Based On High Sensitivity And Spec |
| Target Area | The Device Operates On Radiological Images Of The Human Body. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.2080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFM |
| 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 | 5428 |
| Device | Radiological Computer-assisted Prioritization Software For Lesions |
| Product Code | QFM |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.2080 [🔎] |
TPLC Last Update: 2019-04-02 21:06:06