Medical Device Manufacturer · US , Franklin Park , IL

Villa Sistemi Medicali S.P.A. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1999

Recent clearances: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Villa Sistemi Medicali S.P.A. Radiology ✕

13 devices

1-13 of 13

Cleared Nov 02, 2018

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under...

Radiology · 240d

Cleared Jul 06, 2017

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade...

Radiology · 336d

Cleared Aug 01, 2013

Radiology · 197d

Cleared Jul 22, 2011

ROTOGRAPH EVO 3D

Radiology · 88d

Cleared May 18, 2009

ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191

Radiology · 59d

Cleared Jun 04, 2008

Radiology · 69d

Cleared Mar 25, 2005

Radiology · 57d

Cleared Jul 21, 2003

Radiology · 144d

Cleared Mar 11, 2003

Radiology · 49d

Cleared Sep 01, 2000

Radiology · 24d

Cleared Apr 24, 2000

VISION R/F TILTING TABLE

Radiology · 76d

Cleared Jun 18, 1999

Radiology · 63d

Cleared Jan 14, 1999

Radiology · 24d