Generator, High Voltage, X-ray, Therapeutic

Product Code: KPZ

Radiology Therapeutic X-Ray Systems

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: 892.5900


Radiation TypeIonizing
Radition SafetyAbbreviated
Annual ReportsYes

Products Classified as KPZ

5375Generator, High Voltage, X-ray, TherapeuticX-ray Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5375Generator, High Voltage, X-ray, TherapeuticX-ray Radiation Therapy System.

FDA Consensus Standards

Generator, High Voltage, X-Ray, Therapeutic [28999]21 CFR §892.5900 🔎
Generator, High Voltage, X-Ray, Therapeutic [34832]21 CFR §892.5900 🔎

Pre-market Notifications for KPZ

K912249PATIENT DOSE MONITORTHETA SYSTEMS, INC.
K86046937-701-1 PATIENT DOASE MONITOR WITH DETECTORSVICTOREEN, INC.

Maude Adverse Events

HF COMBI UNIT 300W MONOP.80W.BIPOLARAESCULAP AG2017-03-27
*RADIATIONUNK2002-01-15
VERIFLEXNUCLETRON BV1998-04-02
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