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510(k) K142901

RhythmView Workstation by Topera, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
October 14, 2014
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)
  • 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)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)