510(k) K943602

DI-2000 by Miles Inc., Agfa Division — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
July 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type