ECGenius System— 510(k) K220306

Name: FDA 510(k) clearance K220306
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Substantially Equivalent

Cath Vision Aps

FDA 510(k) clearance K220306 for ECGenius System, Substantially Equivalent on 2022-05-03. Applicant: Cath Vision Aps. Device class: 2.

Clearance details

Applicant: Cath Vision Aps
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2022-02-02
Decision date: 2022-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen N, DK

Download summary PDF View on FDA.gov ↗

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K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

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K223787 — ECGenius System2023-08-04

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.