FDA applicant
Radformation, Inc.
FDA records 17 decisions for Radformation, Inc. (New York, NY) from 2016 to 2026: 17 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and QKB (Radiological Image Processing Software For…). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 12 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Radformation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Radformation, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Radformation, 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) Report