DICOMPACS DX-R WITH FLAT PANEL

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

OEHM UND REHBEIN GMBH

The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Dicompacs Dx-r With Flat Panel.

Pre-market Notification Details

Device IDK141440
510k NumberK141440
Device Name:DICOMPACS DX-R WITH FLAT PANEL
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant OEHM UND REHBEIN GMBH 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm, P.e.
CorrespondentDaniel Kamm, P.e.
OEHM UND REHBEIN GMBH 8870 RAVELLO CT Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-02
Decision Date2014-08-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.