PHILIPS INTURIS DICOM RECORDER

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 Inturis Dicom Recorder.

Pre-market Notification Details

Device IDK993227
510k NumberK993227
Device Name:PHILIPS INTURIS DICOM RECORDER
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 Received1999-09-27
Decision Date1999-12-21
Summary:summary

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