Data / Medical devices / Japan / Ziosoft, Inc.
Ziosoft, Inc.: FDA-registered device maker in Minato-ku Tokyo, Japan, 3 510(k) clearances
Ziosoft, Inc. is registered with the FDA (registration 3006621332) in Minato-ku Tokyo, Japan. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006621332
- Address
- Mitakokusai Bldg. 1-4-28 Mita, Minato-ku Tokyo, Japan, 108-0073
- Owner or operator
- Ziosoft, Inc. (10054027)
- Roles
- Manufacturer
- First device listed
- February 2, 2017
- Registered through
- 2026
- Brand names listed
- Ziostation2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2020 | K200315 | Ziostation2 | LLZ | Substantially Equivalent | Ziosoft, Inc. | accessdata.fda.gov |
| October 9, 2018 | K181892 | Ziostation2 | LLZ | Substantially Equivalent | Ziosoft, Inc. | accessdata.fda.gov |
| November 4, 2015 | K151212 | Ziostation2 | LLZ | Substantially Equivalent | Qi Imaging, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated May 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.