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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040376 ↗

FDA Product Code

LLZ

Models / Variants

Sectra IDS5 Radiology Workstation

Sectra Mpr Package

Sectra 3D Package

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

• Sectra IDS5 Workstation

  Class II

  FDA 510(k) K051315 Active Cleared 15 Jun 2005

• 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

• 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 Sectra IDS5 Radiology Workstation used for?

  The Sectra IDS5 Radiology Workstation is a software-based PACS designed for the visualization and processing of digital radiology images. It receives inputs from various imaging modalities through DICOM or similar standards, enabling clinicians to view, manipulate, and analyze medical images in radiology departments.

• How is the Sectra IDS5 Radiology Workstation supplied and deployed?

  The device is supplied as a software system intended for installation and use in radiology settings. It operates as a PACS platform that processes and displays radiological images, requiring compatible hardware and network infrastructure to function in clinical environments.

• What regulatory clearance does the Sectra IDS5 Radiology Workstation have?

  The Sectra IDS5 Radiology Workstation received FDA 510(k) clearance under submission number K040376 on May 4, 2004. It was determined to be substantially equivalent to legally marketed devices and is classified under product code LLZ with a special clearance type.