IYI — Collimator, Orthovoltage, Therapeutic X-Ray Class II

FDA Device Classification

FDA product code IYI covers "Collimator, Orthovoltage, Therapeutic X-Ray", a Class II medical device regulated under 21 CFR 892.5900. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.