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FDA 510(k)

LuminScan (TM) Imaging System

K-Number: K162466 · 2016-11-29

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2016-11-29
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LuminScan (TM) Imaging System is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2016-11-29 under approval number K162466. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LuminScan (TM) Imaging System?

LuminScan (TM) Imaging System is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K162466.

When was LuminScan (TM) Imaging System approved by the FDA?

LuminScan (TM) Imaging System received FDA 510(k) clearance on 2016-11-29, under approval number K162466.

What company makes LuminScan (TM) Imaging System?

LuminScan (TM) Imaging System is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for LuminScan (TM) Imaging System?

The FDA product code for LuminScan (TM) Imaging System is NQQ.

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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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