The following data is part of a premarket notification filed by Micro-tech (nanjing) Co.,ltd. with the FDA for Luminscan (tm) Imaging System.
| Device ID | K162466 |
| 510k Number | K162466 |
| Device Name: | LuminScan (TM) Imaging System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | MICRO-TECH (NANJING) CO.,LTD. NO. 10 GAOKE THIRD ROAD Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li MICRO-TECH (NANJING) CO.,LTD. NO. 10 GAOKE THIRD ROAD Nanjing, CN 210032 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2016-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26932503570019 | K162466 | 000 |
| 16932503570036 | K162466 | 000 |
| 16932503570043 | K162466 | 000 |
| 16932503570050 | K162466 | 000 |
| 16932503570067 | K162466 | 000 |
| 16932503570074 | K162466 | 000 |
| 16932503570081 | K162466 | 000 |
| 16932503570098 | K162466 | 000 |
| 16932503570104 | K162466 | 000 |
| 16932503570029 | K162466 | 000 |