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FDA 510(k)

Change Healthcare Cardiology

K-Number: K212528 · 2021-10-18

ApplicantChange Healthcare Israel , Ltd.
Decision Date2021-10-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Change Healthcare Cardiology is a medical device manufactured by Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2021-10-18 under approval number K212528. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Change Healthcare Cardiology?

Change Healthcare Cardiology is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Change Healthcare Israel , Ltd.. The 510(k) number is K212528.

When was Change Healthcare Cardiology approved by the FDA?

Change Healthcare Cardiology received FDA 510(k) clearance on 2021-10-18, under approval number K212528.

What company makes Change Healthcare Cardiology?

Change Healthcare Cardiology is manufactured by Change Healthcare Israel , Ltd..

What is the FDA product code for Change Healthcare Cardiology?

The FDA product code for Change Healthcare Cardiology is LLZ.

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025)

Other Devices by Change Healthcare Israel , Ltd.

K181080McKesson Cardiology K230881Change Healthcare Cardiology Hemodynamics™

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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