QLAB Advanced Quantification Software

Automated Radiological Image Processing Software

Philips Healthcare

The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Qlab Advanced Quantification Software.

Pre-market Notification Details

Device IDK191647
510k NumberK191647
Device Name:QLAB Advanced Quantification Software
ClassificationAutomated Radiological Image Processing Software
Applicant Philips Healthcare 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactEri Gremi
CorrespondentEri Gremi
Philips Healthcare 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-20
Decision Date2019-12-20

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