510(k) Report

FDA applicant

Sectra AB

Linköping, SE5 decisions2000–20241 recall

FDA records 5 decisions for Sectra AB (Linköping, SE) from 2000 to 2024: 5 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and PSY (Whole Slide Imaging System). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sectra 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, Radiological3decisions
  • PSYWhole Slide Imaging System1decision
  • QKQDigital Pathology Image Viewing And Management Software1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 20042cite it

What has FDA decided for it lately?

  • K232208Sectra Digital Pathology Module (Version 3.3)Sectra AB · 2024
  • K193054Sectra Digital Pathology ModuleSectra AB · 2020
  • K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
  • K033088Sectra IDS5 Radiology Workstation Version 10.1Sectra AB · 20031 recall
  • K001140IDS5 Image Display SystemSectra AB · 2000

All 5 as Sectra AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033088Easy Vision Workstation Family (for the manipulation and displaying of x-ray images)…Jul 1, 2006

Other applicant names beginning “Sectra”

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

Sectra-Imtec AB 14