Product code IWM— Radiology
LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM
- Classification name
- Synchrotron, Medical
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code IWM
FDA has cleared device under product code IWM, all in 1988, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code IWM
Recent clearances under product code IWM
Data sourced from openFDA. This site is unofficial and independent of the FDA.