FDA 510(k)

Nucleus.io

K-Number: K203249 · 2020-12-04

Decision Date2020-12-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Nucleus.io is the device name listed in this FDA 510(k) record. The listed applicant is Nucleushealth, LLC. It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K203249. 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 Nucleus.io?

Nucleus.io is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Nucleushealth, LLC. The 510(k) number is K203249.

When did Nucleus.io receive FDA 510(k) clearance?

Nucleus.io received FDA 510(k) clearance on 2020-12-04, under 510(k) number K203249.

Who is the listed applicant for Nucleus.io?

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

What is the FDA product code for Nucleus.io?

The FDA product code for Nucleus.io is LLZ.

Other records listing Nucleushealth, LLC 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.

K171130Nucleus Image Management System

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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.