Collimator, X-ray

Product Code: EHB

Dental Medical Diagnostic X-Ray Equipment

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: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 872.1840


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as EHB

5256Collimator, X-rayDental X-ray Position Indicating Device.

Total Product Life Cycle (TPLC) Devices

5256Collimator, X-rayDental X-ray Position Indicating Device.

FDA Consensus Standards

Collimator, X-Ray [37593]21 CFR §872.1840 🔎
Collimator, X-Ray [37630]21 CFR §872.1840 🔎

Pre-market Notifications for EHB

K921355WINGMASTERINNOVATORS, INC.
K903012AUDIOPRAT ENDOSCOPES.C.D.P.I. OF FLORIDA, INC.
K834606X-RAY COLLIMATOR X-CJDKNOCHEN DENTAL LABORATORY
K833558X-RAY SHIELDMOYCO INDUSTRIES, INC.
K781675X-RAY COLLIMATORGENERAL X-RAY, INC.

Maude Adverse Events

2019-01-03

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