MOBILE C-ARM

Image-intensified Fluoroscopic X-ray System, Mobile

ACOMA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Mobile C-arm.

Pre-market Notification Details

Device IDK893617
510k NumberK893617
Device Name:MOBILE C-ARM
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
ContactJames Lambrecht
CorrespondentJames Lambrecht
ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-10
Decision Date1989-07-14

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