510(k) Report

FDA applicant

Syntheticmr AB

Linkoping, SE6 decisions2017–20210 recalls

FDA records 6 decisions for Syntheticmr AB (Linkoping, SE) from 2017 to 2021: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 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 Syntheticmr AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12018: 22019: 12020: 12021: 1
2017high 2 (2018) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Syntheticmr 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K181093SyMRISyntheticmr AB · 20181cites it
  • K203372SyMRISyntheticmr AB · 20211cites it
  • K191036SyMRISyntheticmr AB · 20191cites it
  • K201616SyMRISyntheticmr AB · 20201cites it

What has FDA decided for it lately?

All 6 as Syntheticmr AB →

Other applicant names beginning “Syntheticmr”

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

Syntheticmr AB (Publ.) 2