FDA applicant

Blue X Imaging Srl

Wheeling, IL2 decisions2003–20030 recalls

FDA records 2 decisions for Blue X Imaging Srl (Wheeling, IL) in 2003: 2 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 3 predicates, 0 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, dental panel, where it files most

How often FDA has decided Blue X Imaging Srl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blue X Imaging Srl since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Blue X Imaging Srl’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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Other applicant names beginning “Blue”

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

Blue Belt Technologies, Inc. 22 Blue Sky Bio, LLC 21 Blue Ridge Media Co. 11 Blue Ortho 9 Blue Sky Medical Group Incorporated 4 Blue Planet Industries, Inc. 3 Blue Torch Medical Technologies 2 Blue Sail Medical Co.,Ltd 2 Blue Spark Technologies, Inc. 2 Blue & Red Corp. 1 Blue Focus 1 Blue Gem Sunglasses, Inc. 1

Blue X Imaging Srl

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?

Other applicant names beginning “Blue”