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FDA 510(k)

Avenda Health AI Prostate Cancer Planning Software

K-Number: K221624 · 2022-11-22

ApplicantAvenda Health, Inc.
Decision Date2022-11-22
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Avenda Health AI Prostate Cancer Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is Avenda Health, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221624. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avenda Health AI Prostate Cancer Planning Software?

Avenda Health AI Prostate Cancer Planning Software is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Avenda Health, Inc.. The 510(k) number is K221624.

When did Avenda Health AI Prostate Cancer Planning Software receive FDA 510(k) clearance?

Avenda Health AI Prostate Cancer Planning Software received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221624.

Who is the listed applicant for Avenda Health AI Prostate Cancer Planning Software?

The FDA 510(k) record lists Avenda Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avenda Health AI Prostate Cancer Planning Software?

The FDA product code for Avenda Health AI Prostate Cancer Planning Software is POK.

Other records listing Avenda Health, Inc. 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.

K201687Avenda Health Treatment System

Related Devices (Code: POK)

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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