Direx Systems Corp. - FDA 510(k) Cleared Devices
22
Total
22
Cleared
0
Denied
Direx Systems Corp. has 22 FDA 510(k) cleared medical devices. Based in Natick, US.
Historical record: 22 cleared submissions from 2003 to 2012. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Direx Systems Corp. Filter by specialty or product code using the sidebar.
22 devices
Cleared
Mar 01, 2012
DUET MAGNA
Gastroenterology & Urology
237d
Cleared
Dec 07, 2010
PRONEX
Radiology
74d
Cleared
Oct 26, 2007
TRACKPORT
Radiology
49d
Cleared
Jul 23, 2007
TRACKLEAF-10
Radiology
32d
Cleared
Dec 14, 2006
CROSSPLAN / ACCUSOFT-XL V.4.04
Radiology
27d
Cleared
Oct 20, 2006
INTEGRA SL
Gastroenterology & Urology
85d
Cleared
Oct 05, 2006
ACCUSOFT, ACCUSOFT XL
Radiology
79d
Cleared
Aug 18, 2006
VERT-X
Radiology
46d
Cleared
Jul 21, 2006
MAGIS1
Radiology
32d
Cleared
Mar 10, 2006
MIGUE
Radiology
207d
Cleared
Mar 01, 2006
INTEGRA
Gastroenterology & Urology
61d
Cleared
Feb 21, 2006
DART-12
Radiology
146d
Cleared
May 05, 2005
ACCUCHANGER
Radiology
146d
Cleared
Mar 16, 2005
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
Gastroenterology & Urology
61d
Cleared
Jul 22, 2004
3DSCOPE
Radiology
73d
Cleared
Jul 07, 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
Gastroenterology & Urology
23d
Cleared
Jun 23, 2004
ACCUSOFT
Radiology
120d
Cleared
Apr 28, 2004
TRIPTER X-1 COMPACT
Gastroenterology & Urology
64d
Cleared
Apr 01, 2004
MODIFICATION TO ACCULEAF
Radiology
30d
Cleared
Dec 15, 2003
ACCUSOFT
Radiology
152d
Cleared
Jan 17, 2003
TRIPTER X-1 COMPACT DUET
Gastroenterology & Urology
88d
Cleared
Jan 07, 2003
ACCULEAF
Radiology
256d