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Astronomer Plus System

by Ep Technologies, Inc. 510(k)

Active United States

510(k) K013349

Overview

The Astronomer Plus System is a programmable diagnostic computer classified under Computer, Diagnostic, Programmable (FDA classification DQK), designed for cardiovascular applications. It assists in the real-time visualization and analysis of catheter positioning during complex cardiac mapping procedures, aiding in the diagnosis of arrhythmias by providing spatial orientation of intracardiac electrodes.

This system is supplied as a standalone accessory for use with compatible catheter systems, such as the Constellation Catheter, and is intended for clinical settings requiring electrophysiological mapping. It is not described as sterile or single-use; regulatory submissions indicate it was reviewed under Abbreviated 510(k) clearance (K013349) by the FDA’s Cardiovascular Panel in 2002. No MRI safety or sterility claims are stated in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK013349 Date9 Apr 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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