GEMINI IMAGING SYSTEM

System, X-ray, Tomography, Computed

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Gemini Imaging System.

Pre-market Notification Details

Device IDK013521
510k NumberK013521
Device Name:GEMINI IMAGING SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactColeen A Coleman
CorrespondentMichael Kwan
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-10-23
Decision Date2001-11-07
Summary:summary

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