LuminScan (TM) Imaging System
FDA 510(k) K162466 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK162466
Submission
- Device name
- LuminScan (TM) Imaging System
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- September 2, 2016
- Decision date
- November 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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Questions and answers
When was LuminScan (TM) Imaging System cleared by the FDA?
LuminScan (TM) Imaging System (K162466) received a 510(k) decision of Substantially Equivalent on November 29, 2016, 88 days after the submission was received.
What is the product code of K162466?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.