LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM

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

LIEBEL-FLARSHEIM

The following data is part of a premarket notification filed by Liebel-flarsheim with the FDA for Liebel-flarsheim Direct Digital Imaging System.

Pre-market Notification Details

Device IDK121838
510k NumberK121838
Device Name:LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant LIEBEL-FLARSHEIM 2111 EAST GALBRAITH RD Cincinnati,  OH  45237
ContactCraig Buehler
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-06-22
Decision Date2012-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10746190002826 K121838 000
10746190002819 K121838 000
10746190002475 K121838 000
10746190002468 K121838 000

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