System, Radiation Therapy, Neutron, Medical

Product Code: IWL

Radiology Radioisotope Therapy Devices

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: 892.5300


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as IWL

5289System, Radiation Therapy, Neutron, MedicalMedical Neutron Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5289System, Radiation Therapy, Neutron, MedicalMedical Neutron Radiation Therapy System.

FDA Consensus Standards

System, Radiation Therapy, Neutron, Medical [32087]21 CFR §892.5300 🔎

Pre-market Notifications for IWL

K852804MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYSMEDCYC. CORP.

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