The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Ziostation2.
| Device ID | K200315 |
| 510k Number | K200315 |
| Device Name: | Ziostation2 |
| Classification | System, Image Processing, Radiological |
| Applicant | Ziosoft, Inc. MitaKokusai Bldg., 1-4-28 Mita Minato-ku, JP 108-0073 |
| Contact | Tsuyoshi Nagata |
| Correspondent | Richard Ball Ziosoft USA Inc. 1301 Shoreway Road, Suite 325 Belmont, CA 94002 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-07 |
| Decision Date | 2020-05-05 |