510(k) K212345

AcQMap High Resolution Imaging and Mapping System by Acutus Medical, Inc. — Product Code DQK

K212345 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQMap High Resolution Imaging and Mapping System". The FDA issued a decision of Substantially Equivalent on August 27, 2021. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Acutus Medical, Inc. has at least 10 other 510(k) clearances on record.