510(k) K103782

4D MV-ASSESSMENT 2.0 by Tomtec Imaging Systems GmbH — Product Code DQK

K103782 is an FDA 510(k) premarket notification submitted by Tomtec Imaging Systems GmbH for the device "4D MV-ASSESSMENT 2.0". The FDA issued a decision of Substantially Equivalent on January 27, 2011. 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.