# K212345: AcQMap High Resolution Imaging and Mapping System

- Pathway: 510(k) (Special)
- Applicant: Acutus Medical, Inc.
- Decided: Aug 27, 2021 after 30 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921750 (1992). 17 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201015: AcQMap High Resolution Imaging and Mapping System, Acutus Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K220784: AcQMap High Resolution Imaging and Mapping System (2022), 3 descendants of its own
- K222209: AcQMap High Resolution Imaging and Mapping System (2022), 2 descendants of its own
- K231091: AcQMap High Resolution Imaging and Mapping System (2023), 0 descendants of its own
- K230606: AcQMap® High Resolution Imaging and Mapping System (2023), 0 descendants of its own

## Indications for use
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

Source page: https://510kreport.com/device/K212345
Methodology: https://510kreport.com/methodology