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510(k) K101391

SCANDIA-45 GAMMA CAMERA SYSTEM by Scandia Corporation — Product Code IYX

K101391 is an FDA 510(k) premarket notification submitted by Scandia Corporation for the device "SCANDIA-45 GAMMA CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on August 4, 2010. 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
August 4, 2010
Date Received
May 18, 2010
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