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FDA 510(k)

Change Healthcare Enterprise Viewer

K-Number: K181185 · 2018-08-29

ApplicantChange Healthcare Canada Company
Decision Date2018-08-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Change Healthcare Enterprise Viewer is a medical device manufactured by Change Healthcare Canada Company. It received FDA 510(k) clearance on 2018-08-29 under approval number K181185. 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 Enterprise Viewer?

Change Healthcare Enterprise Viewer is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Change Healthcare Canada Company. The 510(k) number is K181185.

When was Change Healthcare Enterprise Viewer approved by the FDA?

Change Healthcare Enterprise Viewer received FDA 510(k) clearance on 2018-08-29, under approval number K181185.

What company makes Change Healthcare Enterprise Viewer?

Change Healthcare Enterprise Viewer is manufactured by Change Healthcare Canada Company.

What is the FDA product code for Change Healthcare Enterprise Viewer?

The FDA product code for Change Healthcare Enterprise Viewer 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 Canada Company

K210719Change Healthcare Anatomical AI K241981Change Healthcare Stratus Imaging PACS

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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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