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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
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.