The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Ziostation2.
Device ID | K181892 |
510k Number | K181892 |
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 |
Subsequent Product Code | JAK |
Subsequent Product Code | LNH |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-13 |
Decision Date | 2018-10-09 |
Summary: | summary |