Villa Sistemi Medicali S.P.A.
Villa Sistemi Medicali S.P.A. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2018, with 8 FDA device recalls on record.
Top product codes for Villa Sistemi Medicali S.P.A.
FDA recalls by Villa Sistemi Medicali S.P.A.
- Z-0766-2020 — 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 is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
- Z-0763-2020 — Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
- Z-0764-2020 — 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 stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
- Z-0765-2020 — 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 is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
- Z-1430-2017 — Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Z-1429-2017 — Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Z-1427-2017 — Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Z-1428-2017 — Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Villa Sistemi Medicali S.P.A.
- K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- K162190 — Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
- K130109 — ENDOGRAPH DC
- K111152 — ROTOGRAPH EVO 3D
- K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
- K080859 — DRF 4343
- K050190 — APOLLO
- K030634 — ENDOS DC
- K030185 — ENDOS AC/ACP
- K002432 — STRATO X
- K000412 — VISION R/F TILTING TABLE
- K991310 — EXPLOR-X 70
- K984524 — AZTECH 70
Data sourced from openFDA. This site is unofficial and independent of the FDA.