VANTAGE, FOR ADAC GAMMA CAMERAS

System, Tomography, Computed, Emission

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Vantage, For Adac Gamma Cameras.

Pre-market Notification Details

Device IDK943596
510k NumberK943596
Device Name:VANTAGE, FOR ADAC GAMMA CAMERAS
ClassificationSystem, Tomography, Computed, Emission
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactRichard Zablocki
CorrespondentRichard Zablocki
ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-25
Decision Date1995-04-26

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