Medical Device Manufacturer · US , Franklin Park , IL

Villa Sistemi Medicali S.P.A.

13 submissions · 13 cleared · Since 1999
13
Total
13
Cleared
0
Denied

Villa Sistemi Medicali S.P.A. — FDA 510(k) Submissions

Villa Sistemi Medicali S.P.A. has submitted 13 FDA 510(k) premarket notifications since 1999, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, X-ray, Extraoral With Timer, System, X-ray, Extraoral Source, Digital, Table, Radiographic, Tilting, Table, Radiologic, System, X-ray, Fluoroscopic, Image-intensified . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
K180601 · OAS X-ray, Tomography,... · Radiology
Nov 2018 240d
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
K162190 · MUH System, X-ray, Extraoral... · Radiology
Jul 2017 336d
ENDOGRAPH DC
K130109 · EHD Unit, X-ray, Extraoral... · Radiology
Aug 2013 197d
ROTOGRAPH EVO 3D
K111152 · MUH System, X-ray, Extraoral... · Radiology
Jul 2011 88d
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
K090749 · EHD Unit, X-ray, Extraoral... · Radiology
May 2009 59d
DRF 4343
K080859 · JAA System, X-ray,... · Radiology
Jun 2008 69d
APOLLO
K050190 · KXJ Table, Radiologic · Radiology
Mar 2005 57d
ENDOS DC
K030634 · EHD Unit, X-ray, Extraoral... · Radiology
Jul 2003 144d
ENDOS AC/ACP
K030185 · EHD Unit, X-ray, Extraoral... · Radiology
Mar 2003 49d
STRATO X
K002432 · EHD Unit, X-ray, Extraoral... · Radiology
Sep 2000 24d
VISION R/F TILTING TABLE
K000412 · IXR Table, Radiographic, Tilting · Radiology
Apr 2000 76d
EXPLOR-X 70
K991310 · EHD Unit, X-ray, Extraoral... · Radiology
Jun 1999 63d
AZTECH 70
K984524 · EHD Unit, X-ray, Extraoral... · Radiology
Jan 1999 24d
Filters
All13 Radiology 13