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FDA 510(k)

Annalise Enterprise CXR Triage Trauma

K-Number: K222179 · 2023-03-28

ApplicantAnnalise-Ai Pty , Ltd.
Decision Date2023-03-28
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise CXR Triage Trauma is a medical device manufactured by Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-03-28 under approval number K222179. 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. It is manufactured by Annalise-Ai Pty , Ltd.. The 510(k) number is K222179.

When was Annalise Enterprise CXR Triage Trauma approved by the FDA?

Annalise Enterprise CXR Triage Trauma received FDA 510(k) clearance on 2023-03-28, under approval number K222179.

What company makes Annalise Enterprise CXR Triage Trauma?

Annalise Enterprise CXR Triage Trauma is manufactured by Annalise-Ai Pty , Ltd..

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

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

Related PubMed Literature

PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 30719879 Early diagnosis of traumatic intracranial hematomas. Journal of biomedical optics (2019)

Other Devices by Annalise-Ai Pty , Ltd.

K231767Annalise Enterprise CTB Triage Trauma K231384Annalise Enterprise CTB Triage Trauma K231094Annalise Enterprise CTB Triage-OH K223240Annalise Enterprise CTB Triage Trauma K222268Annalise Enterprise CXR Triage Trauma

Related Devices (Code: QFM)

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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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