510(k) K955643

ALARA IMAGING SYSTEM by Denoptix, Inc. — Product Code EGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1996
Date Received
December 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic, Dental
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type