FDA applicant
Southeastern Radiation Products, Inc.
FDA records 2 decisions for Southeastern Radiation Products, Inc. (Sanford, FL) from 2002 to 2004: 2 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IXI (Block, Beam-Shaping, Radiation Therapy). Its devices cite 13 predicates, 0 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 Southeastern Radiation Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Southeastern Radiation Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Southeastern Radiation Products, 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 “Southeastern”
FDA records each applicant name separately; these may or may not be the same firm.