Annalise Enterprise CXR Triage Trauma
K-Number: K222268 · 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 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. It is manufactured by Annalise-Ai Pty , Ltd.. The 510(k) number is K222268.
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 K222268.
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.
Other Devices by Annalise-Ai Pty , Ltd.
Related Devices (Code: QFM)
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.