FDA applicant

Neurologica Corporation, A Subsidiary OF

Danvers, MA1 decision2017–20171 recall

FDA records 1 decision for Neurologica Corporation, A Subsidiary OF (Danvers, MA) in 2017: 1 510(k) clearance. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 1 predicate, 0 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’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2018

2017high 1 (2018) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Neurologica Corporation, A Subsidiary OF by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Neurologica”

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

Neurologica Corporation 8 Neurologica Corporation, A Subsidiary of Samsung… 4 Neurologica Corporation, A Subsidiary of Samsung 2 NeuroLogica Corp., a Samsung Company 1

Neurologica Corporation, A Subsidiary OF

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Neurologica”