FDA 510(k)

Annalise Enterprise

K-Number: K250831 · 2025-04-23

Decision Date2025-04-23

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Annalise Enterprise is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K250831. 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?

Annalise Enterprise is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Annalise-Ai. The 510(k) number is K250831.

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

Annalise Enterprise received FDA 510(k) clearance on 2025-04-23, under 510(k) number K250831.

Who is the listed applicant for Annalise Enterprise?

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?

The FDA product code for Annalise Enterprise 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.

K213941Annalise Enterprise CXR Triage Pneumothorax

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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.