Zonare Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Zonare Medical Systems, Inc.” (first 2008, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 32 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 | 1 | 36 |
| 2013 | 0 | — |
| 2014 | 1 | 29 |
| 2015 | 2 | 22 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 | 6 |
Review panels
- Radiology (6)
Most recent Zonare Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151175 | ZONARE ZS3 Diagnostic Ultrasound System | IYN | 2015-05-15 | 14 |
| K150249 | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | IYN | 2015-03-04 | 29 |
| K141641 | ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2014-07-18 | 29 |
| K120703 | ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM | IYN | 2012-04-13 | 36 |
| K101091 | Z.ONE ULTRA ULTRASOUND SYSTEM | IYN | 2010-06-25 | 67 |
| K082326 | ZONARE ULTRA ULTRASOUND SYSTEM | IYN | 2008-10-08 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Zonare Medical Systems, 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 Zonare Medical Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Zonare Medical Systems, Inc.” (first 2008, latest 2015), 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 Zonare Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zonare Medical Systems, Inc. is 32 days.
Which FDA product codes appear under Zonare Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 6).
Next steps
- See all 6 Zonare Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Zonare Medical Systems, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.