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FDA 510(k)

Change Healthcare Anatomical AI

K-Number: K210719 · 2021-07-20

ApplicantChange Healthcare Canada Company
Decision Date2021-07-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Change Healthcare Anatomical AI is a medical device manufactured by Change Healthcare Canada Company. It received FDA 510(k) clearance on 2021-07-20 under approval number K210719. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Change Healthcare Anatomical AI?

Change Healthcare Anatomical AI is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Change Healthcare Canada Company. The 510(k) number is K210719.

When was Change Healthcare Anatomical AI approved by the FDA?

Change Healthcare Anatomical AI received FDA 510(k) clearance on 2021-07-20, under approval number K210719.

What company makes Change Healthcare Anatomical AI?

Change Healthcare Anatomical AI is manufactured by Change Healthcare Canada Company.

What is the FDA product code for Change Healthcare Anatomical AI?

The FDA product code for Change Healthcare Anatomical AI is QIH.

Related Clinical Trials

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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

K181185Change Healthcare Enterprise Viewer 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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