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FDA 510(k)

Annalise Enterprise CXR Triage Trauma

K-Number: K222268 · 2023-03-28

Decision Date2023-03-28
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise CXR Triage Trauma is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K222268. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Annalise Enterprise CXR Triage Trauma?

Annalise Enterprise CXR Triage Trauma is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K222268.

When did Annalise Enterprise CXR Triage Trauma receive FDA 510(k) clearance?

Annalise Enterprise CXR Triage Trauma received FDA 510(k) clearance on 2023-03-28, under 510(k) number K222268.

Who is the listed applicant for Annalise Enterprise CXR Triage Trauma?

The FDA 510(k) record lists Annalise-Ai Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annalise Enterprise CXR Triage Trauma?

The FDA product code for Annalise Enterprise CXR Triage Trauma is QFM.

Other records listing Annalise-Ai Pty , 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.

Related Devices (Code: QFM)

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.

Official Source

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