The following data is part of a premarket notification filed by Nds Surgical Imaging with the FDA for Dome S10.
| Device ID | K132770 |
| 510k Number | K132770 |
| Device Name: | DOME S10 |
| Classification | System, Image Processing, Radiological |
| Applicant | NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Contact | Jim Leng |
| Correspondent | Jim Leng NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-04 |
| Decision Date | 2014-01-30 |
| Summary: | summary |