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510(k) K123295

RHYTHM VIEW by Topera, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2013
Date Received
October 22, 2012
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)
  • K133305 — RHYTHM VIEW WORKSTATION (December 16, 2013)
  • K130827 — FIRMAP CATHETER (October 31, 2013)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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  • 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)