510(k) Report

FDA applicant

Scandidos AB

Uppsala, SE5 decisions2006–20240 recalls

FDA records 5 decisions for Scandidos AB (Uppsala, SE) from 2006 to 2024: 5 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No 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 Scandidos AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12016: 12019: 12024: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scandidos AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical5decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 246 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K052920DELTA4Scandidos AB · 20061cites it
  • K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+Scandidos AB · 20161cites it

What has FDA decided for it lately?

  • K223234Delta4 InsightScandidos AB · 2024
  • K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)Scandidos AB · 2019
  • K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+Scandidos AB · 2016
  • K151180ScandiDos Delta4 Phantom+Scandidos AB · 2015
  • K052920DELTA4Scandidos AB · 2006

All 5 as Scandidos AB →