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510(k) K142681

ZEUS (ZIO ECG Utilization Service) System by iRhythm Technologies, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
September 19, 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 iRhythm Technologies, Inc.

  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K240029 — Zio AT® device (A100A1001) (October 21, 2024)
  • K222389 — ZEUS System (February 15, 2023)
  • K213409 — ZEUS System (Zio Watch) (July 19, 2022)
  • K202527 — Zio ECG Utilization Software (ZEUS) System (May 21, 2021)
  • K202359 — Zio Monitor (May 21, 2021)
  • K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (August 23, 2019)
  • K181502 — Zio AT ECG Monitoring System, ZEUS System (August 29, 2018)
  • K163512 — Zio AT ECG Monitoring System (June 2, 2017)

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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)