FDA applicant
Varian Medical Systems, X-Ray Products-Infimed
FDA records 2 decisions for Varian Medical Systems, X-Ray Products-Infimed (Liverpool, NY) from 2013 to 2016: 2 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Varian Medical Systems, X-Ray Products-Infimed’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Varian Medical Systems, X-Ray…’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 “Varian”
FDA records each applicant name separately; these may or may not be the same firm.