Sectra Microdose Mammography

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

510(k) Number

K110025 ↗

FDA Product Code

MUE

FDA applicant

Sectra Imtec AB

Device Class

Class II

Regulation

21 CFR Part 892.1715

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

• 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 →