X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

• K Number: K000052
• Device Name: X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
• Manufacturer: DYNARAD CORP.
• Date Cleared: 2000-02-10 ( 34 days)
• Product Code: ITY
• Regulation Number: 892.1760

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 892.1760 Diagnostic x-ray tube housing assembly.

(a)
Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

Summary

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