FDA applicant
Showa X-Ray Co., Ltd.
FDA records 1 decision for Showa X-Ray Co., Ltd. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code IZL (System, X-Ray, Mobile). 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 Showa X-Ray Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Showa X-Ray Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Showa X-Ray Co., 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) ReportOther applicant names beginning “Showa”
FDA records each applicant name separately; these may or may not be the same firm.