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FDA 510(k)

Nucleus Image Management System

K-Number: K171130 · 2017-05-04

ApplicantNucleushealth, LLC
Decision Date2017-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nucleus Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Nucleushealth, LLC. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K171130. 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 Image Management System?

Nucleus Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Nucleushealth, LLC. The 510(k) number is K171130.

When did Nucleus Image Management System receive FDA 510(k) clearance?

Nucleus Image Management System received FDA 510(k) clearance on 2017-05-04, under 510(k) number K171130.

Who is the listed applicant for Nucleus Image Management System?

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 Image Management System?

The FDA product code for Nucleus Image Management System 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.

K203249Nucleus.io

Related Devices (Code: LLZ)

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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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