DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

System, Image Processing, Radiological

OEHM UND REHBEIN GMBH

The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Dicompacs, Model 5.2, Dicompacs Dx-r, Model 1.4.

Pre-market Notification Details

Device IDK091364
510k NumberK091364
Device Name:DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
ClassificationSystem, Image Processing, Radiological
Applicant OEHM UND REHBEIN GMBH 55 NORTHERN BLVD. SUITE 200 Great Neck,  NY  11021
ContactAlan Schwartz
CorrespondentAlan Schwartz
OEHM UND REHBEIN GMBH 55 NORTHERN BLVD. SUITE 200 Great Neck,  NY  11021
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-08
Decision Date2009-12-11
Summary:summary

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