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FDA 510(k)

Annalise Enterprise CTB Triage-OH

K-Number: K231094 · 2023-08-15

ApplicantAnnalise-Ai Pty , Ltd.
Decision Date2023-08-15
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise CTB Triage-OH 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 2023-08-15 under 510(k) number K231094. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Annalise Enterprise CTB Triage-OH?

Annalise Enterprise CTB Triage-OH is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K231094.

When did Annalise Enterprise CTB Triage-OH receive FDA 510(k) clearance?

Annalise Enterprise CTB Triage-OH received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231094.

Who is the listed applicant for Annalise Enterprise CTB Triage-OH?

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 CTB Triage-OH?

The FDA product code for Annalise Enterprise CTB Triage-OH is QAS.

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.

K231767Annalise Enterprise CTB Triage TraumaK231384Annalise Enterprise CTB Triage TraumaK223240Annalise Enterprise CTB Triage TraumaK222268Annalise Enterprise CXR Triage TraumaK222179Annalise Enterprise CXR Triage Trauma

Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

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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