Collimator, Dermatological, Therapeutic X-ray

Product Code: IYL

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 IYL

5327Collimator, Dermatological, Therapeutic X-rayX-ray Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5327Collimator, Dermatological, Therapeutic X-rayX-ray Radiation Therapy System.

FDA Consensus Standards

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

Pre-market Notifications for IYL

K841359FENESTRA HOOKTREACE MEDICAL, INC.

Global Unique Device Identification Database

04987670100796Collimator, dermatological, therapeutic x-ray

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