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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2016-11-29 under 510(k) 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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K162466.

When did LuminScan (TM) Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for LuminScan (TM) Imaging System?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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