Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) 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. The listed applicant is Change Healthcare Israel , Ltd.. The 510(k) number is K212528.

When did Change Healthcare Cardiology receive FDA 510(k) clearance?

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

Who is the listed applicant for Change Healthcare Cardiology?

The FDA 510(k) record lists Change Healthcare Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Cardiology?

The FDA product code for Change Healthcare Cardiology is LLZ.

Other records listing Change Healthcare Israel , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230881Change Healthcare Cardiology Hemodynamics™K181080McKesson Cardiology

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

↑