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510(k) K133305

RHYTHM VIEW WORKSTATION by Topera, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2013
Date Received
October 28, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Topera, Inc.

  • K151245 — Rhythm View Workstation (non-streaming, steaming option) (September 15, 2015)
  • K142901 — RhythmView Workstation (December 19, 2014)
  • K142182 — FRIMAP ADAPTER CONNECTOR (MAC) (September 9, 2014)
  • K130827 — FIRMAP CATHETER (October 31, 2013)
  • K123295 — RHYTHM VIEW (April 24, 2013)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)