QLVA PLUS

System, Image Processing, Radiological

SANDERS DATA SYSTEMS, LLC.

The following data is part of a premarket notification filed by Sanders Data Systems, Llc. with the FDA for Qlva Plus.

Pre-market Notification Details

Device IDK963859
510k NumberK963859
Device Name:QLVA PLUS
ClassificationSystem, Image Processing, Radiological
Applicant SANDERS DATA SYSTEMS, LLC. 3980 BIBBITS DR. Palo Alto,  CA  94303
ContactWilliam Sanders
CorrespondentWilliam Sanders
SANDERS DATA SYSTEMS, LLC. 3980 BIBBITS DR. Palo Alto,  CA  94303
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-26
Decision Date1996-12-18

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