# K251344: OptiMap™ System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 28, 2025 after 28 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: 10 generations back to K000248 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230008: Ablamap® System, Ablacon, Inc. (2023) Summary page 5.

## Indications for use
The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

Source page: https://510kreport.com/device/K251344
Methodology: https://510kreport.com/methodology