510(k) Report

FDA applicant

Neurologica Corporation, A Subsidiary of Samsung

Danvers, MA2 decisions2023–20250 recalls

FDA records 2 decisions for Neurologica Corporation, A Subsidiary of Samsung (Danvers, MA) from 2023 to 2025: 2 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 2 predicates, 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 Neurologica Corporation, A Subsidiary of Samsung’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Neurologica Corporation, A Subsidiary of Samsung by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung · 20231cites it
  • K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 20251cites it

What has FDA decided for it lately?

  • K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
  • K223447OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung · 2023

All 2 as Neurologica Corporation, A Subsidiary of Samsung →

Other applicant names beginning “Neurologica”

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

Neurologica Corporation 8Neurologica Corporation, A Subsidiary of Samsung… 4Neurologica Corporation, A Subsidiary OF 1NeuroLogica Corp., a Samsung Company 1