# Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/computer-assisted-detection-devices-applied-to-radiology-images-and-radiology-device-data-premarket-notification-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/8201b588-c213-4c45-b25e-e2450d8463c7

> FDA guidance document: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 28, 2022. Get complete insights and analysis.

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## Details

- Title: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions:  Guidance for Industry and Food and Drug Administration 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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