PX-100 PORTABLE X-RAY GENERATOR

System, X-ray, Mobile

ACOMA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Px-100 Portable X-ray Generator.

Pre-market Notification Details

Device IDK921116
510k NumberK921116
Device Name:PX-100 PORTABLE X-RAY GENERATOR
ClassificationSystem, X-ray, 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 CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-09
Decision Date1992-10-05

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