LuminScan (TM) Imaging System— 510(k) K162466

Name: FDA 510(k) clearance K162466
Creator: U.S. Food and Drug Administration
Published: 2016-11-29

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K162466 for LuminScan (TM) Imaging System, Substantially Equivalent on 2016-11-29. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2016-09-02
Decision date: 2016-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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