De Gotzen S.R.L.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “De Gotzen S.R.L.” (first 2014, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 239 days. Since 2017 the median was 186 days, against 116 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 |
|---|---|---|
| 2014 | 1 | 303 |
| 2015 | 0 | — |
| 2016 | 1 | 293 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 186 |
| 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 De Gotzen S.R.L. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (5)
Most recent De Gotzen S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | OAS | 2020-11-18 | 176 |
| K191719 | X-MIND Trium | MUH | 2020-02-20 | 239 |
| K192165 | Acteon Imaging Suite | LLZ | 2020-02-11 | 186 |
| K160166 | X-MIND trium | OAS | 2016-11-15 | 293 |
| K132378 | X-MIND UNITY | EHD | 2014-05-30 | 303 |
Recalls
openFDA lists no recalls under a recalling firm named De Gotzen S.R.L..
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 De Gotzen S.R.L.?
FDA lists 5 510(k) clearances under the applicant name “De Gotzen S.R.L.” (first 2014, latest 2020), 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 De Gotzen S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name De Gotzen S.R.L. is 239 days. Since 2017: 186 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under De Gotzen S.R.L.?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 De Gotzen S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code OAS, De Gotzen S.R.L.'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.