510(k) Report

FDA applicant

Solutions For Tomorrow AB

Vackelsang, SE3 decisions2017–20250 recalls

FDA records 3 decisions for Solutions For Tomorrow AB (Vackelsang, SE) from 2017 to 2025: 3 510(k) clearances. All are in product code IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 2 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 Solutions For Tomorrow AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2017: 12025: 2
2017high 2 (2025) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Solutions For Tomorrow AB by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZLSystem, X-Ray, Mobile3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 143 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 153 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K241980!M1Solutions For Tomorrow AB · 20251cites it
  • K170607!M1Solutions For Tomorrow AB · 20171cites it

What has FDA decided for it lately?

  • K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025
  • K241980!M1Solutions For Tomorrow AB · 2025
  • K170607!M1Solutions For Tomorrow AB · 2017

All 3 as Solutions For Tomorrow AB →

Other applicant names beginning “Solutions”

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

Solutions, Inc. 1