FDA applicant

Mobius Imaging, LLC

Shirley, MA3 decisions2013–20188 recalls

FDA records 3 decisions for Mobius Imaging, LLC (Shirley, MA) from 2013 to 2018: 3 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 3 predicates, 2 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Mobius Imaging”.

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 Mobius Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2025

2013high 2 (2017) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Mobius Imaging, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Mobius”

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

Mobius Medical Systems, LP 3 Mobius Mobility 2

Mobius Imaging, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mobius”