FDA applicant
Alphatek Corp.
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
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.
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.
See the 510(k) Report