Change Healthcare Cardiology— 510(k) K212528

Name: FDA 510(k) clearance K212528
Creator: U.S. Food and Drug Administration
Published: 2021-10-18

Substantially Equivalent

Change Healthcare Israel , Ltd.

FDA 510(k) clearance K212528 for Change Healthcare Cardiology, Substantially Equivalent on 2021-10-18. Applicant: Change Healthcare Israel , Ltd.. Device class: 2.

Clearance details

Applicant: Change Healthcare Israel , Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-08-11
Decision date: 2021-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holon, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Change Healthcare Israel , Ltd.

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K230881 — Change Healthcare Cardiology Hemodynamics2023-09-11
K181080 — McKesson Cardiology2018-05-24

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.