FDA applicant
Imaging and X-Ray Intl., Inc.
FDA records 1 decision for Imaging and X-Ray Intl., Inc. (Tustin, CA) in 1993: 1 510(k) clearance. All are in product code IZO (Generator, High-Voltage, 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 Imaging and X-Ray Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Imaging and X-Ray Intl., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Imaging and X-Ray Intl., Inc.’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 “Imaging”
FDA records each applicant name separately; these may or may not be the same firm.