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FDA 510(k)

Quantib ND

K-Number: K182564 · 2018-12-27

ApplicantQuantib B.V.
Decision Date2018-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Quantib ND is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2018-12-27 under approval number K182564. 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 Quantib ND?

Quantib ND is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Quantib B.V.. The 510(k) number is K182564.

When was Quantib ND approved by the FDA?

Quantib ND received FDA 510(k) clearance on 2018-12-27, under approval number K182564.

What company makes Quantib ND?

Quantib ND is manufactured by Quantib B.V..

What is the FDA product code for Quantib ND?

The FDA product code for Quantib ND is LLZ.

Related Clinical Trials

NCT06298305 Artificial Intelligence & Prostate Cancer COMPLETED

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K153351Quantib Brain 1 K163013Quantib Brain 1.2 K173939Quantib Brain K202501Quantib Prostate K200899Quantib AI Node K221106Quantib Prostate

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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.

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