510(k) K091364

DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 by Oehm Und Rehbein GmbH — Product Code LLZ

K091364 is an FDA 510(k) premarket notification submitted by Oehm Und Rehbein GmbH for the device "DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4". The FDA issued a decision of Substantially Equivalent on Dec 11, 2009. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Oehm Und Rehbein GmbH has 4 other 510(k) clearances on record.