MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

Collimator, Automatic, Radiographic

RALCO S.R.L.

The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for Model R302dacs/a Automatic X-ray Collimator.

Pre-market Notification Details

Device IDK072780
510k NumberK072780
Device Name:MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
ClassificationCollimator, Automatic, Radiographic
Applicant RALCO S.R.L. P.O. BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
RALCO S.R.L. P.O. BOX 7007 Deerfield,  IL  60015
Product CodeIZW  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-28
Decision Date2007-11-26
Summary:summary

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