Zebra Medical Vision, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Zebra Medical Vision, Ltd.” (first 2018, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 111 days, against 125 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 259 |
| 2019 | 3 | 92 |
| 2020 | 3 | 101 |
| 2021 | 2 | 216 |
| 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 Zebra Medical Vision, Ltd. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 5 | 5 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 1 | 1 |
Review panels
- Radiology (9)
Most recent Zebra Medical Vision, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211803 | HealthPPT | QFM | 2021-12-15 | 187 |
| K210085 | HealthCCSng | JAK | 2021-09-15 | 245 |
| K202487 | HealthJOINT | LLZ | 2020-12-04 | 95 |
| K200905 | HealthMammo | QFM | 2020-07-16 | 101 |
| K192901 | HealthVCF | QFM | 2020-05-12 | 210 |
| K192320 | HealthCXR | QFM | 2019-11-26 | 92 |
| K190424 | HealthICH | QAS | 2019-06-13 | 111 |
| K190362 | HealthPNX | QFM | 2019-05-06 | 80 |
| K172983 | HealthCCS | JAK | 2018-06-13 | 259 |
Recalls
openFDA lists no recalls under a recalling firm named Zebra Medical Vision, Ltd..
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 Zebra Medical Vision, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Zebra Medical Vision, Ltd.” (first 2018, latest 2021), across 4 product codes 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 Zebra Medical Vision, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zebra Medical Vision, Ltd. is 111 days. Since 2017: 111 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zebra Medical Vision, Ltd.?
The most frequent FDA product codes under this applicant name are QFM (Radiological Computer-Assisted Prioritization Software For Lesions, 5); JAK (System, X-Ray, Tomography, Computed, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 9 Zebra Medical Vision, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QFM, Zebra Medical Vision, Ltd.'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.