510(k) Report

FDA applicant

Sectra-Imtec AB

Denton, TX14 decisions1996–20114 recalls

FDA records 14 decisions for Sectra-Imtec AB (Denton, TX) from 1996 to 2011: 14 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMB (Device, Digital Image Storage, Radiological). Its devices cite 12 predicates, 6 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Sectra Imtec AB”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sectra-Imtec AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sectra-Imtec AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological9decisions
  • LMBDevice, Digital Image Storage, Radiological2decisions
  • LMDSystem, Digital Image Communications, Radiological1decision
  • KGIDensitometer, Bone1decision
  • MUEFull Field Digital, System, X-Ray, Mammographic1decision

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSectra-Imtec AB · 20047cite it
  • K031590Sectra Orthopedic PackageSectra-Imtec AB · 20035cite it
  • K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 20035cite it
  • K002936Modification to IDS5 Image Display SystemSectra-Imtec AB · 20004cite it
  • K063093Sectra Workstation, Version 11.1Sectra Imtec AB · 20063cite it
  • K050196Sectra IDS5 WorkstationSectra Imtec AB · 20053cite it

What has FDA decided for it lately?

  • K110025Sectra Microdose MammographySectra Imtec AB · 2011
  • K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2Sectra Imtec AB · 2008
  • K063093Sectra Workstation, Version 11.1Sectra Imtec AB · 20061 recall
  • K051315Modification to: Sectra IDS5 WorkstationSectra Imtec AB · 20051 recall
  • K050196Sectra IDS5 WorkstationSectra Imtec AB · 2005
  • K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSectra-Imtec AB · 2004
  • K033712Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
  • K031590Sectra Orthopedic PackageSectra-Imtec AB · 2003

All 9 as Sectra-Imtec AB →All 5 as Sectra Imtec AB →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K051315Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM…Jan 30, 2009
  • K983447Easy Access Image Management System with CL.Net.Feb 16, 2005
  • K983447Easy Access Software releases 1.1, 5.2, 6.2 & 7.2Jun 27, 2003
  • K983447Easy Access PACS System with software Release 5, 6.2, or 7.2Feb 13, 2002

Other applicant names beginning “Sectra-Imtec”

FDA records each applicant name separately; these may or may not be the same firm.

Sectra AB 5