Rhythm View Workstation

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

510(k) Number

K133305 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Rhythm View

  Class II

  FDA 510(k) K123295 Active Cleared 24 Apr 2013

• Firmap Catheter

  Class II

  FDA 510(k) K130827 Active Cleared 31 Oct 2013

• Rhythm View Workstation (non-streaming, steaming option)

  Class II

  FDA 510(k) K151245 Active Cleared 15 Sep 2015

• Frimap Adapter Connector (Mac)

  Class II

  FDA 510(k) K142182 Active Cleared 9 Sep 2014

• RhythmView Workstation

  Class II

  FDA 510(k) K142901 Active Cleared 19 Dec 2014

• Rhythmview (Tm)

  Class II

  FDA 510(k) K110878 Active Cleared 23 Sep 2011

• What is the Rhythm View Workstation used for?

  The Rhythm View Workstation is a computerized system designed to assist in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals and displaying them in a visual format for cardiovascular settings.

• How is the Rhythm View Workstation supplied?

  The device is supplied as a Class II cardiac workstation manufactured by Topera, Inc. It includes the necessary hardware and software components for analyzing and visualizing cardiac signals in clinical environments.

• What regulatory approvals does the Rhythm View Workstation have?

  The Rhythm View Workstation has received FDA 510(k) clearance with K-number K133305, determined to be substantially equivalent to predicate devices for the diagnosis of complex cardiac arrhythmias.

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

  The Rhythm View Workstation is a computerized workstation system designed for repeated use in clinical settings. It is not a single-use device but requires proper maintenance and calibration according to manufacturer instructions.