Illumeo System

System, Image Processing, Radiological

Philips Medical Systems Technologies, Ltd.

The following data is part of a premarket notification filed by Philips Medical Systems Technologies, Ltd. with the FDA for Illumeo System.

Pre-market Notification Details

Device IDK173588
510k NumberK173588
Device Name:Illumeo System
ClassificationSystem, Image Processing, Radiological
Applicant Philips Medical Systems Technologies, Ltd. PO Box 325 Building 34 Haifa,  IL 3100202
ContactYoram Levy
CorrespondentYoram Levy
Philips Medical Systems Technologies Ltd. 31 Haavoda Street Binyamina,  IL 3100202
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838087958 K173588 000
00884838093997 K173588 000

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