# Villa Sistemi Medicali S.P.A.

- Location (FDA's records): Buccinasco, IT
- FDA decisions: 13 (1999–2018): 13 510(k) clearances
- Product codes: EHD (7), MUH (2), JAA (1), KXJ (1), IXR (1), OAS (1)
- Predicates its devices cite: 15 (5 its own); citations of its devices by later devices: 13 (5 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Owandy: 2 (https://510kreport.com/company/owandy)
- Afp Imaging Corp.: 1 (https://510kreport.com/company/afp-imaging)
- Nical Spa: 1 (https://510kreport.com/company/nical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Shimadzu Corp.: 1 (https://510kreport.com/company/shimadzu)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)
- Vivi S.R.L.: 1 (https://510kreport.com/company/vivi)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Firms that cite its devices most
- De Gotzen S.R.L.: 3 (https://510kreport.com/company/de-gotzen)
- Owandy: 2 (https://510kreport.com/company/owandy)
- Cmt Medical Technologies, Ltd.: 1 (https://510kreport.com/company/cmt-medical-technologies)
- Vivi S.R.L.: 1 (https://510kreport.com/company/vivi)
- Ray Co., Ltd.: 1 (https://510kreport.com/company/ray)

## Its most-cited devices
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 (2009), cited by 3
- K111152: Rotograph Evo 3D (2011), cited by 2
- K002432: Strato X (2000), cited by 2
- K162190: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) (2017), cited by 1
- K080859: DRF 4343 (2008), cited by 1
- K130109: Endograph DC (2013), cited by 1

## Recent decisions
- K180601: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (Nov 2, 2018)
- K162190: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) (Jul 6, 2017)
- K130109: Endograph DC (Aug 1, 2013)
- K111152: Rotograph Evo 3D (Jul 22, 2011)
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 (May 18, 2009)
- K080859: DRF 4343 (Jun 4, 2008)
- K050190: Apollo (Mar 25, 2005)
- K030634: Endos DC (Jul 21, 2003)

Source page: https://510kreport.com/company/villa-sistemi-medicali