510(k) K001592

ECHOCOM, IMAGECOM, DOKUCOM by Tomtec Imaging Systems GmbH — Product Code DQK

K001592 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "ECHOCOM, IMAGECOM, DOKUCOM". The FDA issued a decision of Substantially Equivalent on June 16, 2000. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Tomtec Imaging Systems GmbH has at least 10 other 510(k) clearances on record.