PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING

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 Easy Vision Family Workstation Option Cardirac Scoring.

Pre-market Notification Details

Device IDK002942
510k NumberK002942
Device Name:PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton,  CT  06484 -0197
ContactPeter Altman
CorrespondentPeter Altman
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton,  CT  06484 -0197
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-21
Decision Date2000-12-19

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