510(k) K071195

KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 by Ani-Kal Ii, LLC — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
April 30, 2007
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