# K253861: Acorys Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Corify Care S.L
- Decided: Apr 13, 2026 after 131 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: 9 generations back to K000248 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162440: CardioInsight Cardiac Mapping System, Cardioinsight Technologies, Inc. (2016) Summary page 9.

## Indications for use
The ACORYS MAPPING SYSTEM is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. The ACORYS MAPPING SYSTEM is indicated for patients with cardiac arrhythmia and/or cardiac electrical disorders. The ACORYS MAPPING SYSTEM is indicated for use in adults. The ACORYS MAPPING SYSTEM can be used in regular medical consultations or in Hospitals during cardiac electrophysiological interventions. The ACORYS MAPPING SYSTEM is indicated for use in intact skin only.

Source page: https://510kreport.com/device/K253861
Methodology: https://510kreport.com/methodology