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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 the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Canada Company. It received FDA 510(k) clearance on 2021-07-20 under 510(k) 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. The listed applicant is Change Healthcare Canada Company. The 510(k) number is K210719.

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

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

Who is the listed applicant for Change Healthcare Anatomical AI?

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

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

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

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Other records listing Change Healthcare Canada Company as applicant

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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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