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Rhythm View Workstation (non-streaming)

by Abbott Electrophysiology

510(k) K161240

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 NumberK161240 Date10 Aug 2016ClearedStatusActive

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  • Withdrawn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 Rhythm View Workstation (non-streaming) is a computerized diagnostic system designed for use in electrophysiology laboratories. It accepts electrical signals from multi-polar electrophysiology catheters as input and uses proprietary algorithms to process these signals, computing the spatial organization of electrical activity. The system identifies rotors or focal beat sources and outputs this information to assist physicians in analyzing cardiac arrhythmias.

The device is intended to analyze electrogram and electrocardiogram signals and display them in a visual format to aid in the diagnosis of complex cardiac arrhythmias. It is manufactured by Abbott Electrophysiology and is supplied as a non-streaming workstation. The system is designed for use in clinical settings by trained physicians and is subject to regulatory oversight under FDA 510(k) procedures.

Other devices from Abbott Electrophysiology

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 Rhythm View Workstation used for?

    It is a computerized diagnostic system for electrophysiology laboratories that accepts electrical signals from multi-polar catheters. It uses proprietary algorithms to compute the spatial organization of electrical activity, identifying rotors or focal beat sources to assist physicians in analyzing cardiac arrhythmias.

  • How is the device supplied?

    The device is supplied as a non-streaming workstation by Abbott Electrophysiology. It is intended for use in clinical settings by trained physicians and operates as a standalone computerized system rather than a streaming-capable platform.

  • Is the Rhythm View Workstation single-use or reusable?

    The device is a computerized workstation, which implies it is a reusable piece of capital equipment intended for repeated use across multiple diagnostic procedures in a clinical laboratory setting. It is not described as a single-use disposable item.

  • What types of signals does it analyze?

    The system is designed to analyze electrogram and electrocardiogram signals. It processes these inputs to display them in a visual format, aiding in the diagnosis of complex cardiac arrhythmias by highlighting electrical patterns.

  • What is the regulatory status of this device?

    The device is subject to regulatory oversight under FDA 510(k) procedures. It was reviewed under the traditional clearance pathway with a determination of substantial equivalence, falling under the cardiovascular advisory committee review category.