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510(k) K110878

RHYTHMVIEW (TM) by Topera, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
March 30, 2011
Clearance Type
Traditional
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)
  • K133305 — RHYTHM VIEW WORKSTATION (December 16, 2013)
  • K130827 — FIRMAP CATHETER (October 31, 2013)
  • K123295 — RHYTHM VIEW (April 24, 2013)

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  • 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)