Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Code: 5426
Product Code(s):
QBS Definition: A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography,
Device Classification Information
| Device Type ID | 5426 |
| Device Name | Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Physical State | Software Device That Receives Radiological Images As An Input And Provides A Concurrent Read For Presence Or Absence Of Fracture (detection And Diagnosis) As An Output |
| Technical Method | Analyzes Radiological Images Using Machine Learning Algorithms To Detect And Diagnose Fracture. |
| Target Area | Radiological Images Of Anatomical Sites That Main Contain Fracture. |
| 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 | 892.2090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBS |
| 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 | 5426 |
| Device | Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Product Code | QBS |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 892.2090 [🔎] |
TPLC Last Update: 2019-04-02 21:06:04