Zenition 70

Interventional Fluoroscopic X-ray System

Philips Medical Systems Nederland BV

The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Zenition 70.

Pre-market Notification Details

Device IDK212813
510k NumberK212813
Device Name:Zenition 70
ClassificationInterventional Fluoroscopic X-ray System
Applicant Philips Medical Systems Nederland BV Veenpluis 4-6 Best,  NL 5684pc
ContactSwapnil Sharadkumar Jain
CorrespondentSwapnil Sharadkumar Jain
Philips Medical Systems Nederland BV Veenpluis 4-6 Best,  NL 5684pc
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2021-10-01

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