Medical Device Manufacturer · US , Aubrey , TX

Sectra-Imtec AB - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1996

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sectra-Imtec AB Radiology ✕

14 devices

1-12 of 14

Cleared Apr 28, 2011

SECTRA MICRODOSE MAMMOGRAPHY

Radiology · 115d

Cleared Jun 12, 2008

SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2

Radiology · 16d

Cleared Nov 07, 2006

SECTRA WORKSTATION, VERSION 11.1

Radiology · 28d

Cleared Jun 15, 2005

MODIFICATION TO: SECTRA IDS5 WORKSTATION

Radiology · 26d

Cleared Feb 24, 2005

SECTRA IDS5 WORKSTATION

Radiology · 28d

Cleared May 04, 2004

SECTRA IDS5 RADIOLOGY WORKSTATION

Radiology · 77d

Cleared Dec 23, 2003

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

Radiology · 27d

Cleared Oct 02, 2003

SECTRA ORTHOPEDIC PACKAGE

Radiology · 134d

Cleared Jun 07, 2002

SECTRA OSTEOPOROSIS PACKAGE

Radiology · 28d

Cleared Oct 17, 2000

MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

Radiology · 26d

Cleared Oct 29, 1998

WISE (II) IMAGE MANAGEMENT SYSTEM

Radiology · 29d

Cleared Mar 12, 1997

SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)

Radiology · 79d