510(k) Report

FDA applicant

Neurologica Corporation, A Subsidiary of Samsung Electronics

Danvers, MA4 decisions2017–20221 recall

FDA records 4 decisions for Neurologica Corporation, A Subsidiary of Samsung Electronics (Danvers, MA) from 2017 to 2022: 4 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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 Electronics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 22020: 12022: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2017high 1 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Neurologica Corporation, A Subsidiary of Samsung Electronics 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?

  • JAKSystem, X-Ray, Tomography, Computed4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 126 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 20172cite it
  • K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 20221cites it
  • K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 20201cites it

What has FDA decided for it lately?

  • K211711OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2022
  • K202526OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 20201 recall
  • K172539CereTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
  • K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017

All 4 as Neurologica Corporation, A Subsidiary of Samsung Electronics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202526OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be…Jun 6, 2023Class II

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 2Neurologica Corporation, A Subsidiary OF 1NeuroLogica Corp., a Samsung Company 1