Home / Companies / Villa Sistemi Medicali S.P.A.

Villa Sistemi Medicali S.P.A.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
13
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0765-2020Class IIApollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-November 4, 2019
Z-0766-2020Class IIApollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray eNovember 4, 2019
Z-0763-2020Class IIJuno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routNovember 4, 2019
Z-0764-2020Class IIApollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote cNovember 4, 2019
Z-1430-2017Class IIApollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of rouDecember 27, 2016
Z-1429-2017Class IIApollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of roDecember 27, 2016
Z-1427-2017Class IIJuno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine December 27, 2016
Z-1428-2017Class IIApollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 December 27, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy RadiNovember 2, 2018
K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)July 6, 2017
K130109ENDOGRAPH DCAugust 1, 2013
K111152ROTOGRAPH EVO 3DJuly 22, 2011
K090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191May 18, 2009
K080859DRF 4343June 4, 2008
K050190APOLLOMarch 25, 2005
K030634ENDOS DCJuly 21, 2003
K030185ENDOS AC/ACPMarch 11, 2003
K002432STRATO XSeptember 1, 2000
K000412VISION R/F TILTING TABLEApril 24, 2000
K991310EXPLOR-X 70June 18, 1999
K984524AZTECH 70January 14, 1999