FDA applicant

Applied Spectral Imaging, Ltd.

Haifa, IL8 decisions1997–20150 recalls

FDA records 8 decisions for Applied Spectral Imaging, Ltd. (Haifa, IL) from 1997 to 2015: 8 510(k) clearances. Most are in product codes NTH (System, Automated Scanning Microscope And…) and LNJ (Analyzer, Chromosome, Automated). Its devices cite 16 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Applied Spectral Imaging”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Applied Spectral Imaging, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Applied Spectral Imaging, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Applied Spectral Imaging, Ltd.

Which product codes does it file in?

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?