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FDA 510(k)

Annalise Enterprise CXR Triage Pneumothorax

K-Number: K213941 · 2022-02-24

ApplicantAnnalise-Ai
Decision Date2022-02-24
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise CXR Triage Pneumothorax is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K213941. 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 Pneumothorax?

Annalise Enterprise CXR Triage Pneumothorax is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Annalise-Ai. The 510(k) number is K213941.

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

Annalise Enterprise CXR Triage Pneumothorax received FDA 510(k) clearance on 2022-02-24, under 510(k) number K213941.

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

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

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

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

Other records listing Annalise-Ai 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.

K250831Annalise Enterprise

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

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.

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