Company ยท US
Villa Sistemi Medicali S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2018. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 2018 | K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) Villa Sistemi Medicali S.P.A., IT | OAS |
| Jul 6, 2017 | K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) Villa Sistemi Medicali S.P.A., IT | MUH |
| Aug 1, 2013 | K130109 | ENDOGRAPH DC Villa Sistemi Medicali S.P.A., IT | EHD |
| Jul 22, 2011 | K111152 | ROTOGRAPH EVO 3D Villa Sistemi Medicali S.P.A., IT | MUH |
| May 18, 2009 | K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 Villa Sistemi Medicali S.P.A., IT | EHD |
| Jun 4, 2008 | K080859 | DRF 4343 Villa Sistemi Medicali S.P.A., IT | JAA |
| Mar 25, 2005 | K050190 | APOLLO Villa Sistemi Medicali S.P.A. | KXJ |
| Jul 21, 2003 | K030634 | ENDOS DC Villa Sistemi Medicali S.P.A. | EHD |
| Mar 11, 2003 | K030185 | ENDOS AC/ACP Villa Sistemi Medicali S.P.A. | EHD |
| Sep 1, 2000 | K002432 | STRATO X Villa Sistemi Medicali S.P.A. | EHD |
| Apr 24, 2000 | K000412 | VISION R/F TILTING TABLE Villa Sistemi Medicali S.P.A. | IXR |
| Jun 18, 1999 | K991310 | EXPLOR-X 70 Villa Sistemi Medicali S.P.A. | EHD |
| Jan 14, 1999 | K984524 | AZTECH 70 Villa Sistemi Medicali S.P.A. | EHD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system Open, Classified |
KXJ | K050190 |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system Open, Classified |
KXJ | K050190 |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationa Open, Classified |
KXJ | K050190 |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures. Open, Classified |
KXJ | K050190 |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo EZ; Model: 9784152036
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | K050190 |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo DRF; Model: 9784220831
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | K050190 |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo; Models: 9784000131
9784000231
9784020131
9784020231
9784100231
9784120131
9784120231
9784130131
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general Terminated |
KXJ | K050190 |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Juno DRF; Model: 709020
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | K050190 |