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510(k) K221321

MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System by Ge Medical Systems Information Technologies, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2022
Date Received
May 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
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)
  • K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (December 13, 2023)
  • 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)

Other clearances for product code DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)