References

Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices
November 14, 1998
Supersedes the Guidance for the Content and Review Of a Magnetic Resonance Diagnostic Device 510(k) Application (8/2/88).
U.S. Department Of Health and Human Services, Food and Drug Administration
Document 340

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices
July 14, 2003
Supersedes “Guidance for Magnetic Resonance Diagnostic Devices – Criteria for Significant Risk Investigations” (9/29/1997).
U.S. Department of Health and Human Services, Food and Drug Administration
Document 793