PRECEDENCE SPECT/CT IMAGING SYSTEM

System, Tomography, Computed, Emission

ADAC LABORATORIES

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

Pre-market Notification Details

Device IDK051351
510k NumberK051351
Device Name:PRECEDENCE SPECT/CT IMAGING SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactColeen A Coleman
CorrespondentMorten Simon Christensen
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-05-24
Decision Date2005-06-08
Summary:summary

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