PHILIPS EASYVISION WORKSTATION

System, Image Processing, Radiological

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Easyvision Workstation.

Pre-market Notification Details

Device IDK974207
510k NumberK974207
Device Name:PHILIPS EASYVISION WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactPeter Altman
CorrespondentPeter Altman
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-10
Decision Date1998-01-22
Summary:summary

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