FDA applicant

Elekta Neuromag OY

Stockholm, SE4 decisions2004–20100 recalls

FDA records 4 decisions for Elekta Neuromag OY (Stockholm, SE) from 2004 to 2010: 4 510(k) clearances. All are in product code OLX (Source Localization Software For…). Its devices cite 6 predicates, 5 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, neurology panel, where it files most

How often FDA has decided Elekta Neuromag OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Elekta”

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

Elekta Instrument AB 35 Elekta, Ltd. 22 Elekta Solutions AB 15 Elekta Instruments, Inc. 8 Elekta Oncology Systems, Ltd. 5 Elekta Implants, SA 2 Elekta Radiosurgery, Inc. 1 Elekta Inc. D/B/A Nucletron Corporation 1

Elekta Neuromag OY

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Elekta”