APOLLO GAMMA CAMERA SYSTEM

System, Tomography, Computed, Emission

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Apollo Gamma Camera System.

Pre-market Notification Details

Device IDK062298
510k NumberK062298
Device Name:APOLLO GAMMA CAMERA SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactAnnie Wright
CorrespondentMorten Simon Christensen
UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose,  CA  95131 -1230
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-08-08
Decision Date2006-08-23
Summary:summary

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