Sectra Osteoporosis Package

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

510(k) Number

K021527 ↗

FDA Product Code

KGI

Device Class

Class II

Regulation

21 CFR Part 892.1170

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

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

  Class II

  FDA 510(k) K040376 Active Cleared 4 May 2004

See all devices from Sectra-Imtec AB →