FDA applicant
R2 Technology, Inc.
FDA records 5 decisions for R2 Technology, Inc. (Sunnyvale, CA) from 2002 to 2005: 5 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and OEB (Lung Computed Tomography System…). Its devices cite 13 predicates, 3 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 R2 Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for R2 Technology, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like R2 Technology, 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