510(k) Report

FDA applicant

Alphatek Corp.

Chicago, IL5 decisions1992–20030 recalls

FDA records 5 decisions for Alphatek Corp. (Chicago, IL) from 1992 to 2003: 5 510(k) clearances. All are in product code IXW (Processor, Radiographic-Film, Automatic). 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 Alphatek Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alphatek Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alphatek Corp.’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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