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

Source: https://www.keypedia.com/guidances/guidance-document/clinical-performance-assessment-considerations-for-computer-assisted-detection-devices-applied-to-radiology-images-and-radiology-device-data-in-premarket-notification-510k-submissions-guidance-for-industry-and-fda-staff/cba45f13-a519-4f3d-b5c9-5415b512670e

> FDA guidance document: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions:  Guidance for Industry and FDA Staff. Issue date: September 28, 2022. Get complete insights and analysis.

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## Details

- Title: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2022-09-28
- Last Changed: 2022-09-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2009-D-0503">FDA-2009-D-0503</a>

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