510(k) Report

FDA applicant

Villa Sistemi Medicali S.P.A.

Buccinasco, IT13 decisions1999–201816 recalls

FDA records 13 decisions for Villa Sistemi Medicali S.P.A. (Buccinasco, IT) from 1999 to 2018: 13 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 15 predicates, 5 of them its own earlier devices. 16 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Villa Sistemi Medicali S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 12009: 12011: 12013: 12017: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2019

2012: 12013: 12014: 12015: 12016: 82019: 4
2007high 8 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Villa Sistemi Medicali S.P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Villa Sistemi Medicali S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer7decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision
  • KXJTable, Radiologic1decision
  • IXRTable, Radiographic, Tilting1decision
  • OASX-Ray, Tomography, Computed, Dental1decision

Whose devices does it build on?

Its devices cite 15 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 20093cite it
  • K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 20112cite it
  • K002432Strato XVilla Sistemi Medicali S.P.A. · 20002cite it
  • K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A. · 20171cites it
  • K080859DRF 4343Villa Sistemi Medicali S.P.A. · 20081cites it
  • K130109Endograph DCVilla Sistemi Medicali S.P.A. · 20131cites it

What has FDA decided for it lately?

  • K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A. · 2018
  • K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A. · 2017
  • K130109Endograph DCVilla Sistemi Medicali S.P.A. · 2013
  • K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 20111 recall
  • K090749Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191Villa Sistemi Medicali S.P.A. · 2009
  • K080859DRF 4343Villa Sistemi Medicali S.P.A. · 2008
  • K050190ApolloVilla Sistemi Medicali S.P.A. · 200515 recalls
  • K030634Endos DCVilla Sistemi Medicali S.P.A. · 2003

All 13 as Villa Sistemi Medicali S.P.A. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K050190Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo…Nov 4, 2019Class II
  • K050190Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled…Nov 4, 2019Class II
  • K050190Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table…Nov 4, 2019Class II
  • K050190Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems…Nov 4, 2019Class II
  • K050190Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems…Dec 27, 2016Class II
  • K050190Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems…Dec 27, 2016Class II