Device, Beam Limiting, X-ray, Therapeutic

Product Code: KQA

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 KQA

5376Device, Beam Limiting, X-ray, TherapeuticX-ray Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5376Device, Beam Limiting, X-ray, TherapeuticX-ray Radiation Therapy System.

FDA Consensus Standards

Device, Beam Limiting, X-Ray, Therapeutic [28999]21 CFR §892.5900 🔎
Device, Beam Limiting, X-Ray, Therapeutic [34832]21 CFR §892.5900 🔎

Pre-market Notifications for KQA

K914784PAPILLION PROCTOSCOPEOLDELFT CORP. OF AMERICA
K885126PHILIPS RT250 COLLIMATOR (PK8050)PERKINS MFG. CO.
K844180THE MCP-70-SE SYSTEMELLIS PHARMACEUTICAL CONSULTING, INC.
K790168COLLIMATOR, BILATERIALCMSI

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