INSPECT/PROSPECT

System, Tomography, Computed, Emission

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Inspect/prospect.

Pre-market Notification Details

Device IDK952564
510k NumberK952564
Device Name:INSPECT/PROSPECT
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 Received1995-06-02
Decision Date1995-11-22

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