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 IDK200974
510k NumberK200974
Device Name:QLAB Advanced Quantification Software
ClassificationAutomated Radiological Image Processing Software
Applicant Philips Healthcare 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactTravis Catania
CorrespondentTravis Catania
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 Received2020-04-13
Decision Date2020-06-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.