Virtual C DRF-NEO Digital Imaging System

Interventional Fluoroscopic X-ray System

Portavision Medical LLC

The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Virtual C Drf-neo Digital Imaging System.

Pre-market Notification Details

Device IDK212557
510k NumberK212557
Device Name:Virtual C DRF-NEO Digital Imaging System
ClassificationInterventional Fluoroscopic X-ray System
Applicant Portavision Medical LLC 800 Central Avenue Jefferson,  LA  70121
ContactTerry Ancar
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-13
Decision Date2021-09-24

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