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FDA 510(k)

Annalise Enterprise

K-Number: K253818 · 2026-03-03

ApplicantHarrison-AI Medical Pty, Ltd.
Decision Date2026-03-03
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise is the device name listed in this FDA 510(k) record. The listed applicant is Harrison-AI Medical Pty, Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253818. 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?

Annalise Enterprise is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Harrison-AI Medical Pty, Ltd.. The 510(k) number is K253818.

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

Annalise Enterprise received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253818.

Who is the listed applicant for Annalise Enterprise?

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

What is the FDA product code for Annalise Enterprise?

The FDA product code for Annalise Enterprise is QAS.

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.

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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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