The following data is part of a premarket notification filed by Hamamatsu Photonics K.k. with the FDA for Nanozoomer S360md Slide Scanner System.
| Device ID | K213883 |
| 510k Number | K213883 |
| Device Name: | NanoZoomer S360MD Slide Scanner System |
| Classification | Whole Slide Imaging System |
| Applicant | Hamamatsu Photonics K.K. 812, Joko-cho, Higashi-ku Hamamatsu City, JP 431-3196 |
| Contact | Shinichi Fujisaka |
| Correspondent | Jeffrey Gibbs Hyman, Phelps & McNamara, P.C 700 Thirteenth Street NW, Suite 1200 DC, DC 20005 |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582389010659 | K213883 | 000 |