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510(k) K081757

VERISTA IMAGING ISOCAM II GAMMA CAMERA by Verista Imaging, Inc. — Product Code IYX

K081757 is an FDA 510(k) premarket notification submitted by Verista Imaging, Inc. for the device "VERISTA IMAGING ISOCAM II GAMMA CAMERA". The FDA issued a decision of Substantially Equivalent on August 15, 2008. 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 15, 2008
Date Received
June 20, 2008
Clearance Type
Special
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