軟體醫材的分類及審查

CADe: Computer Aided Detection (電腦輔助偵測) 

  FDA: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

  FDA: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions

CADx: Computer Aided Diagnosis (電腦輔助診斷)

CAT: Computer Aided Triage (電腦輔助篩檢)

### 參考資料

各主要國家醫療器材軟體上市審查制度及變更管理方向之比較, 作者: 楊惇筑