Villa Sistemi Medicali S.P.A.: FDA clearances and approvals
Villa Sistemi Medicali S.P.A. has 13 FDA 510(k) clearances (first 1999, latest 2018), across 6 product codes in 1 review panel. Median 510(k) review time: 69 days. openFDA lists 8 product recalls by a recalling firm named Villa Sistemi Medicali S.P.A.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 197 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 336 |
| 2018 | 1 | 240 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Villa Sistemi Medicali S.P.A.'s cleared 510(k)s took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 7 | 7 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
- Radiology (13)
Most recent Villa Sistemi Medicali S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | OAS | 2018-11-02 | 240 |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | MUH | 2017-07-06 | 336 |
| K130109 | ENDOGRAPH DC | EHD | 2013-08-01 | 197 |
| K111152 | ROTOGRAPH EVO 3D | MUH | 2011-07-22 | 88 |
| K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | EHD | 2009-05-18 | 59 |
| K080859 | DRF 4343 | JAA | 2008-06-04 | 69 |
| K050190 | APOLLO | KXJ | 2005-03-25 | 57 |
| K030634 | ENDOS DC | EHD | 2003-07-21 | 144 |
| K030185 | ENDOS AC/ACP | EHD | 2003-03-11 | 49 |
| K002432 | STRATO X | EHD | 2000-09-01 | 24 |
3 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-11-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Villa Sistemi Medicali S.P.A. have?
Villa Sistemi Medicali S.P.A. has 13 FDA 510(k) clearances (first 1999, latest 2018), across 6 product codes in 1 review panel.
How long does FDA take to clear Villa Sistemi Medicali S.P.A.'s 510(k)s?
The median time from FDA receipt to decision across Villa Sistemi Medicali S.P.A.'s cleared 510(k)s is 69 days.
What devices does Villa Sistemi Medicali S.P.A. make?
Its most frequent FDA product codes are EHD (Unit, X-Ray, Extraoral With Timer, 7); MUH (System, X-Ray, Extraoral Source, Digital, 2); IXR (Table, Radiographic, Tilting, 1).
Has Villa Sistemi Medicali S.P.A. had device recalls?
openFDA lists 8 product recalls in 2 recall events by a recalling firm whose name matches Villa Sistemi Medicali S.P.A; the most recent began 2019-11-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Villa Sistemi Medicali S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Villa Sistemi Medicali S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.