FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.

Image-intensified Fluoroscopic X-ray System, Mobile

VARIAN ASSOC., INC.

The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Flouroscope, Mobile C-arm Image Intens..

Pre-market Notification Details

Device IDK760429
510k NumberK760429
Device Name:FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-13
Decision Date1976-08-23

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