Ziosoft, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ziosoft, Inc.” (first 2007, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 88 |
| 2019 | 0 | — |
| 2020 | 1 | 88 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ziosoft, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
Review panels
- Radiology (6)
Most recent Ziosoft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200315 | Ziostation2 | LLZ | 2020-05-05 | 88 |
| K181892 | Ziostation2 | LLZ | 2018-10-09 | 88 |
| K091262 | MR CARDIAC FUNCTION ANALYSIS | LLZ | 2009-06-29 | 61 |
| K083446 | CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING | LLZ | 2009-03-31 | 130 |
| K083084 | CT BRAIN PERFUSION FOR ZIOSTATION | LLZ | 2008-12-19 | 64 |
| K070205 | ZIOSTATION | LLZ | 2007-03-23 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Ziosoft, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ziosoft, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ziosoft, Inc.” (first 2007, latest 2020), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ziosoft, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ziosoft, Inc. is 76 days.
Which FDA product codes appear under Ziosoft, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6).
Next steps
- See all 6 Ziosoft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Ziosoft, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.