Home / 510(k) Clearances / K231870

510(k) K231870

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System by Ge Medical Systems Information Technologies, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
June 26, 2023
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 Ge Medical Systems Information Technologies, Inc.

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client (December 12, 2024)
  • K233810 — Portrait VSM (April 25, 2024)
  • K234130 — Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer A (March 20, 2024)
  • K230626 — Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (August 11, 2023)
  • K230145 — ONE-CUF (March 14, 2023)
  • K222586 — Mural Clinical Viewer (December 21, 2022)
  • K221904 — EK12 V2 Algorithm (December 20, 2022)
  • K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (October 18, 2022)

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)