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Guidance Documents/Guidance-Document/Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry

Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 2, 1998

December 13, 2023

Center for Devices and Radiological Health

879ea6d9-805d-4eb5-927d-6b14a8477e8e

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