510(k) clearance

STAR Apollo™ Mapping System

FDA 510(k) source

510(k) number

K263380

Applicant

Rhythm AI, Ltd.

Decision date

Oct 23, 2026

Date received

Sep 24, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

DQK

Device type

Computer, Diagnostic, Programmable

Device class

Class II

Regulation

21 CFR 870.1425

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

London, GB