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510(k) K212662

AliveCor QT Service by AliveCor, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2022
Date Received
August 23, 2021
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 AliveCor, Inc.

  • K252589 — Corvair Monza (January 9, 2026)
  • K231010 — Corvair (June 7, 2024)
  • K232035 — Impala (June 7, 2024)
  • K220350 — KardiaMobile 6L (May 25, 2022)
  • K211668 — KardiaMobile Card (November 30, 2021)
  • K210753 — KardiaMobile 6L (June 30, 2021)
  • K201985 — KardiaAI (November 12, 2020)
  • K191406 — KardiaMobile, KardiaStation (January 24, 2020)
  • K183319 — Triangle System (May 10, 2019)
  • K182396 — KardiaMobile, KardiaStation (April 12, 2019)

Other clearances for product code DQK

  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • 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)