# K170948: AcQMap High Resolution Imaging and Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Oct 16, 2017 after 200 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: 6 generations back to K921750 (1992). 12 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130594: Ensite Velocity System, St Jude Medical (2013) Summary page 5.
- K130243: Ilab Ultrasound Imaging System, Boston Scientific Corp (2013) Summary page 5.

## Most influential descendants
- K190131: AcQMap High Resolution Imaging and Mapping System (2019), 9 descendants of its own
- K191392: AcQMap High Resolution Imaging and Mapping System (2019), 8 descendants of its own
- K193013: AcQMap High Resolution Imaging and Mapping System (2020), 7 descendants of its own
- K201015: AcQMap High Resolution Imaging and Mapping System (2020), 5 descendants of its own
- K212345: AcQMap High Resolution Imaging and Mapping System (2021), 4 descendants of its own

## Indications for use
The AcQMap® High Resolution Imaging and Mapping 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 dipole 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.

Source page: https://510kreport.com/device/K170948
Methodology: https://510kreport.com/methodology