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510(k) K904599

D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM by Digital Design, Inc. — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1991
Date Received
October 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
Review Panel
RA
Submission Type

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