Synchrotron, Medical

Product Code: IWM

Radiology Medical Accelerators

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.5050


Radiation TypeIonizing
Radition SafetyAbbreviated
Annual ReportsYes

Products Classified as IWM

5290Synchrotron, MedicalMedical Charged-particle Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5290Synchrotron, MedicalMedical Charged-particle Radiation Therapy System.

FDA Consensus Standards

Synchrotron, Medical [31229]21 CFR §892.5050 🔎
Synchrotron, Medical [28999]21 CFR §892.5050 🔎
Synchrotron, Medical [34832]21 CFR §892.5050 🔎
Synchrotron, Medical [32775]21 CFR §892.5050 🔎
Synchrotron, Medical [32087]21 CFR §892.5050 🔎

Pre-market Notifications for IWM

K872369LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEMLOMA LINDA UNIVERSITY MEDICAL CENTER

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