CORDLESS COMPACT MOBILE X-RAY SYSTEM

System, X-ray, Mobile

MEDISON RADIOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Medison Radiology Systems, Inc. with the FDA for Cordless Compact Mobile X-ray System.

Pre-market Notification Details

Device IDK002685
510k NumberK002685
Device Name:CORDLESS COMPACT MOBILE X-RAY SYSTEM
ClassificationSystem, X-ray, Mobile
Applicant MEDISON RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. Deerfield,,  IL  60015
ContactJohn W Lee
CorrespondentJohn W Lee
MEDISON RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. Deerfield,,  IL  60015
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-28
Decision Date2000-09-15

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