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 a medical device manufactured by Nucleushealth, LLC. It received FDA 510(k) clearance on 2017-05-04 under approval 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. It is manufactured by Nucleushealth, LLC. The 510(k) number is K171130.
When was Nucleus Image Management System approved by the FDA?
Nucleus Image Management System received FDA 510(k) clearance on 2017-05-04, under approval number K171130.
What company makes Nucleus Image Management System?
Nucleus Image Management System is manufactured by Nucleushealth, LLC.
What is the FDA product code for Nucleus Image Management System?
The FDA product code for Nucleus Image Management System is LLZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.