510(k) K011466

QED DIODE DETECTORS, MODELS 1112-1116 by Sun Nuclear Corp. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
May 14, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type