KRYSTALRAD (ATAL8)

System, X-ray, Stationary

MEDICATECH USA

The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Krystalrad (atal8).

Pre-market Notification Details

Device IDK102285
510k NumberK102285
Device Name:KRYSTALRAD (ATAL8)
ClassificationSystem, X-ray, Stationary
Applicant MEDICATECH USA 8870 RAVELLO COURT Naples,  FL  34114
ContactJohn Ross
CorrespondentJohn Ross
MEDICATECH USA 8870 RAVELLO COURT Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-12
Decision Date2011-01-03
Summary:summary

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