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Alternanas Processing System, Ch 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System

by Cambridge Heart, Inc.

510(k) K012206

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012206 Date12 Oct 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alternans Processing System adds T-wave alternans diagnostic capabilities to standard stress test systems and ECG recording devices. It is embodied in two legally marketed products: the Model CH2000 Cardiac Diagnostic System and the Heartwave Alternans Processing System. This system enables the measurement and recording of T-Wave alternans at rest and during treadmill, ergometer, electrophysiological, and pharmacologic stress testing.

The system is intended for use with computer-based ECG systems that include the feature for T-Wave alternans measurement. It is supplied as a diagnostic system with specific model numbers and reference codes. The device received FDA 510(k) clearance with the K number K012206 and product code DQK, classified under the Cardiovascular advisory committee.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Alternans Processing System used for?

    The Alternans Processing System adds T-wave alternans diagnostic capabilities to standard stress test systems and ECG recording devices, enabling measurement and recording of T-Wave alternans at rest and during various stress testing methods.

  • How is the Alternans Processing System supplied?

    The system is supplied as a diagnostic system with specific model numbers and reference codes, embodied in two legally marketed products: the Model CH2000 Cardiac Diagnostic System and the Heartwave Alternans Processing System.

  • What regulatory approvals does the Alternans Processing System have?

    The device received FDA 510(k) clearance with K number K012206 and product code DQK, classified under the Cardiovascular advisory committee, with a decision date of 2001-10-12.

  • What types of stress testing can be performed with this system?

    The system enables measurement and recording of T-Wave alternans during treadmill, ergometer, electrophysiological, and pharmacologic stress testing, as well as at rest.