PI808 MOBILE C-ARM IMAGE INTENSIFIER

System, X-ray, Fluoroscopic, Image-intensified

PRECISE OPTICS

The following data is part of a premarket notification filed by Precise Optics with the FDA for Pi808 Mobile C-arm Image Intensifier.

Pre-market Notification Details

Device IDK820178
510k NumberK820178
Device Name:PI808 MOBILE C-ARM IMAGE INTENSIFIER
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant PRECISE OPTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-22
Decision Date1982-03-04

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