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510(k) K071195

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

K071195 is an FDA 510(k) premarket notification submitted by Ani-Kal Ii, LLC for the device "KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5". The FDA issued a decision of Substantially Equivalent on June 20, 2007. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100.

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

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FDA data resources