Medical Device Manufacturer · US , Natick , MA

Direx Systems Corp. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2003

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Direx Systems Corp. Radiology ✕

15 devices

1-15 of 15

Cleared Dec 07, 2010

Radiology · 74d

Cleared Oct 26, 2007

Radiology · 49d

Cleared Jul 23, 2007

Radiology · 32d

Cleared Dec 14, 2006

CROSSPLAN / ACCUSOFT-XL V.4.04

Radiology · 27d

Cleared Oct 05, 2006

ACCUSOFT, ACCUSOFT XL

Radiology · 79d

Cleared Aug 18, 2006

Radiology · 46d

Cleared Jul 21, 2006

Radiology · 32d

Cleared Mar 10, 2006

Radiology · 207d

Cleared Feb 21, 2006

Radiology · 146d

Cleared May 05, 2005

Radiology · 146d

Cleared Jul 22, 2004

Radiology · 73d

Cleared Jun 23, 2004

Radiology · 120d

Cleared Apr 01, 2004

MODIFICATION TO ACCULEAF

Radiology · 30d

Cleared Dec 15, 2003

Radiology · 152d

Cleared Jan 07, 2003

Radiology · 256d