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FDA 510(k)

Advantis Platform

K-Number: K222975 · 2023-03-01

ApplicantAdvantis Medical Imaging Single Member P.C.
Decision Date2023-03-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advantis Platform is the device name listed in this FDA 510(k) record. The listed applicant is Advantis Medical Imaging Single Member P.C.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K222975. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advantis Platform?

Advantis Platform is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Advantis Medical Imaging Single Member P.C.. The 510(k) number is K222975.

When did Advantis Platform receive FDA 510(k) clearance?

Advantis Platform received FDA 510(k) clearance on 2023-03-01, under 510(k) number K222975.

Who is the listed applicant for Advantis Platform?

The FDA 510(k) record lists Advantis Medical Imaging Single Member P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advantis Platform?

The FDA product code for Advantis Platform is LLZ.

Other records listing Advantis Medical Imaging Single Member P.C. 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.

K202808Brainance MD

Related Devices (Code: LLZ)

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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