Collimator, Orthovoltage, Therapeutic X-ray

Product Code: IYI

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 IYI

5324Collimator, Orthovoltage, Therapeutic X-rayX-ray Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5324Collimator, Orthovoltage, Therapeutic X-rayX-ray Radiation Therapy System.

FDA Consensus Standards

Collimator, Orthovoltage, Therapeutic X-Ray [28999]21 CFR §892.5900 🔎
Collimator, Orthovoltage, Therapeutic X-Ray [34832]21 CFR §892.5900 🔎

Pre-market Notifications for IYI

K914821CRS RADIATION BEAM SCANNERCONSOLIDATED RADIATION SERVICES, INC.
K90093237-702 AND 37-703 PC RAINBOWVICTOREEN, INC.

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