Clearance Summary
LuminScan (TM) Imaging System received FDA 510(k) clearance under submission number K162466, sponsored by Micro-Tech (Nanjing) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-11-29.
- Submission: K162466
- Applicant / Sponsor: Micro-Tech (Nanjing) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2016-11-29
Classification & Regulation
This clearance is catalogued under FDA product code NQQ and 21 CFR 892.1560, within the Radiology review panel as a Class II device.