KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM

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

MEDICATECH USA

The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Krystalrad New Seriesdigital Radiographic Portable Retrofit System.

Pre-market Notification Details

Device IDK130377
510k NumberK130377
Device Name:KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant MEDICATECH USA 8870 RAVELLO COURT Naples,  FL  34114
ContactDaniel Kamm, P.e.
CorrespondentDaniel Kamm, P.e.
MEDICATECH USA 8870 RAVELLO COURT Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-14
Decision Date2013-05-17
Summary:summary

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