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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K011466
Device Name QED DIODE DETECTORS, MODELS 1112-1116
Applicant
SUN NUCLEAR CORP.
425-A PINEDA COURT
MELBOURNE,  FL  32940
Applicant Contact JIM MIXON
Correspondent
SUN NUCLEAR CORP.
425-A PINEDA COURT
MELBOURNE,  FL  32940
Correspondent Contact JIM MIXON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/14/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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