Advanced Diffusion Analysis (ADA) Application

System, Image Processing, Radiological

Philips Medical Systems Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Advanced Diffusion Analysis (ada) Application.

Pre-market Notification Details

Device IDK173467
510k NumberK173467
Device Name:Advanced Diffusion Analysis (ADA) Application
ClassificationSystem, Image Processing, Radiological
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best Best Noord-brabant,  NL 5684 Pc
ContactYoram Levy
CorrespondentYoram Levy
Qsite 31 Haavoda St. Binyamina,  IL 30500
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-08
Decision Date2017-12-12
Summary:summary

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