IWM — Synchrotron, Medical Class II

FDA Device Classification

FDA product code IWM covers "Synchrotron, Medical", a Class II medical device regulated under 21 CFR 892.5050. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
IWM
Device Class
Class II
Regulation Number
892.5050
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K872369loma linda university medical centerLOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEMFebruary 22, 1988