IntelliSpace Portal Platform

System, Image Processing, Radiological

PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Intellispace Portal Platform.

Pre-market Notification Details

Device IDK162025
510k NumberK162025
Device Name:IntelliSpace Portal Platform
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. VEENPLUIS 4-6 Room 542A Best,  NL 5684 Pc
ContactIlana Ben Moshe
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-07-22
Decision Date2016-10-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838086449 K162025 000
00884838075894 K162025 000
00884838089808 K162025 000
00884838093621 K162025 000
00884838115613 K162025 000
00884838121553 K162025 000

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