510(k) Report

FDA applicant

Neurologica Corporation

Danvers, MA8 decisions2005–20252 recalls

FDA records 8 decisions for Neurologica Corporation (Danvers, MA) from 2005 to 2025: 8 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and KPS (System, Tomography, Computed, Emission). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 6 of them its own earlier devices. 2 recalls are 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’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12011: 12014: 12017: 12022: 12024: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2020: 12023: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Neurologica Corporation by year, 2007–2026Sources: 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, Computed7decisions
  • KPSSystem, Tomography, Computed, Emission1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 163 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 6 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.

  • K051765Ceretom, Model NL3000Neurologica Corporation · 20056cite it
  • K102677Bodytom NL 4000Neurologica Corporation · 20113cite it
  • K233767OmniTom EliteNeurologica Corporation · 20242cite it
  • K090811Inspira HD, Model: NL1000Neurologica Corporation · 20091cites it
  • K213649BodyTom 64Neurologica Corporation · 20221cites it
  • K171183OmniTomNeurologica Corporation · 20171cites it

What has FDA decided for it lately?

  • K250928OmniTom Elite with PCDNeurologica Corporation · 2025
  • K233767OmniTom EliteNeurologica Corporation · 2024
  • K213649BodyTom 64Neurologica Corporation · 2022
  • K171183OmniTomNeurologica Corporation · 20172 recalls
  • K142697NExCT 7Neurologica Corporation · 2014
  • K102677Bodytom NL 4000Neurologica Corporation · 2011
  • K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009
  • K051765Ceretom, Model NL3000Neurologica Corporation · 2005

All 8 as Neurologica Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K202526OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be…Jun 6, 2023Class II
  • K171183OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software…Jul 15, 2020Class II

Other applicant names beginning “Neurologica”

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

Neurologica Corporation, A Subsidiary of Samsung… 4Neurologica Corporation, A Subsidiary of Samsung 2Neurologica Corporation, A Subsidiary OF 1NeuroLogica Corp., a Samsung Company 1