Radiological Computer-assisted Triage And Notification Software
Device Code: 5425
Product Code(s):
QAS Definition: Radiological Computer-assisted Triage And Notification Software 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 Radiolo
Device Classification Information
| Device Type ID | 5425 |
| Device Name | Radiological Computer-assisted Triage And Notification Software |
| 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. |
| Target Area | The Device Operates On Radiological Images Of The Human Body. |
| 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 | 892.2080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAS |
| 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 | 5425 |
| Device | Radiological Computer-assisted Triage And Notification Software |
| Product Code | QAS |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.2080 [🔎] |
TPLC Last Update: 2019-04-02 21:06:03