Draft Guidances for Industry and Food and Drug Administration Staff; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device

1 organizations filed 1 public comment on Draft Guidances for Industry and Food and Drug Administration Staff; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device, at the Food and Drug Administration. The comment window closed 2379d ago.

Commenters (1)

• Medical Imaging & Technology Alliancetrade assoc.

  1 filing · confidence 97%