ATAL-8

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

ATLAIM

The following data is part of a premarket notification filed by Atlaim with the FDA for Atal-8.

Pre-market Notification Details

Device IDK113812
510k NumberK113812
Device Name:ATAL-8
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant ATLAIM 81 SEACOUNTRY LANE Rancho Santa Margarita,  CA  92688
ContactDaniel Kamm
CorrespondentDaniel Kamm
ATLAIM 81 SEACOUNTRY LANE Rancho Santa Margarita,  CA  92688
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-23
Decision Date2012-05-03
Summary:summary

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