FDA applicant
X-Ray Systems
FDA records 4 decisions for X-Ray Systems (Fraser, MI) from 1985 to 1989: 4 510(k) clearances. Most are in product codes IWY (Holder, Head, Radiographic) and IYB (Tube Mount, X-Ray, Diagnostic). 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 X-Ray Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for X-Ray Systems since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like X-Ray Systems’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