FDA applicant

Aspect Imaging, Ltd.

Industrial Area Hevel Modi’In., IL6 decisions2013–20260 recalls

FDA records 6 decisions for Aspect Imaging, Ltd. (Industrial Area Hevel Modi’In., IL) from 2013 to 2026: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 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 Aspect Imaging, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013high 2 (2026) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

Planning a device like Aspect Imaging, Ltd.’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 “Aspect”

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

Aspect Medical Systems, Inc. 25 Aspect Vision Care, Ltd. 5 Aspect Electronics, Inc. 3

Aspect Imaging, Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Aspect”