510(k) K110384

DILON 6800 ACELLA (ACELLA) by Dilon Technologies, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2011
Date Received
February 10, 2011
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