FDA applicant

Spectrum Dynamics, Ltd.

Kfar Saba, IL3 decisions2006–20161 recall

FDA records 3 decisions for Spectrum Dynamics, Ltd. (Kfar Saba, IL) from 2006 to 2016: 3 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 8 predicates, 1 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 Spectrum Dynamics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Spectrum Dynamics, 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 “Spectrum”

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

Spectrum Medical, Ltd. 23 Spectrum Designs, Inc. 18 Spectrum X-Ray Corp. 9 Spectrum Dynamics Medical, Ltd. 8 Spectrum Spine, LLC 8 Spectrum Vascular 6 Spectrum Co. 3 Spectrum Medical Technologies, Inc. 3 Spectrum Diagnostic, Inc. 3 Spectrum Antimicrobials, Inc. 1 Spectrum Antimicrobials, Inc. (Subsidiary of… 1 Spectrum Spine IP Holdings, LLC 1

Spectrum Dynamics, 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?

What has been recalled?

Other applicant names beginning “Spectrum”