Sectra IDS5 Workstation

• • Terminated Z-0412-2011 FDA Unclassified (pre-2012) ·initiated 30 Jan 2009

  Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.

Full name

Modification to: Sectra IDS5 Workstation

510(k) Number

K051315 ↗

FDA Product Code

LLZ

FDA applicant

Sectra Imtec AB

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Modification to IDS5 Image Display System

  Class II

  FDA 510(k) K002936 Active Cleared 17 Oct 2000

• Trs 2000 Teleradiology System

  Class II

  FDA 510(k) K961983 Active Cleared 13 Aug 1996

• Sectra Microdose Mammography

  Class II

  FDA 510(k) K110025 Active Cleared 28 Apr 2011

• Imageserver 2000 Picture Archiving System

  Class I

  FDA 510(k) K963395 Active Cleared 25 Oct 1996

• Sectra IDS5 Radiology Workstation; Sectra Mpr Package; Sectra 3D Package

  Class II

  FDA 510(k) K040376 Active Cleared 4 May 2004

• Smiic (Sectra Medical Image Input Controller)

  Class I

  FDA 510(k) K965161 Active Cleared 12 Mar 1997

See all devices from Sectra-Imtec AB →

• What is the primary function of the Sectra Ids5 Workstation?

  The Sectra Ids5 Workstation is designed to serve as a medical imaging system that supports clinical workflows in radiology environments by providing tools for the display and processing of diagnostic images.

• What is the regulatory status of this device?

  This device has received FDA 510k clearance, which indicates that the modification to the Sectra Ids5 platform has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• How is this specific version of the workstation supplied?

  This device is supplied as a modification to the existing Sectra Ids5 platform, allowing for updated functionality within the established imaging system architecture.