U.S. FDA Medical Device X-Ray Collimator Requirements
FDA Medical Device Definition: A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.
FDA X-Ray Collimator Label Requirements and Exceptions
FDA X-Ray Collimator Import Information
FDA X-Ray Collimator Detentions (X-Ray Collimator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- X-Ray Collimator Manufacturers (X-Ray Collimator Suppliers)
- X-Ray Collimator Distributors
- X-Ray Collimator Processors
- X-Ray Collimator Repackers
- X-Ray Collimator Relabelers
- X-Ray Collimator Exporters
- X-Ray Collimator Importers
For more information about X-Ray Collimator Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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