Radlink GPS

Solid State X-ray Imager (flat Panel/digital Imager)

RADLINK, INC.

The following data is part of a premarket notification filed by Radlink, Inc. with the FDA for Radlink Gps.

Pre-market Notification Details

Device IDK142718
510k NumberK142718
Device Name:Radlink GPS
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant RADLINK, INC. 815 N. Nash St. El Sugundo,  CA  90245
ContactBrian Kordich
CorrespondentDaniel Kamm
Kamm & Associates 8870 RAVELLO CT. Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-23
Decision Date2014-12-17
Summary:summary

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