K Number
K954161Device Name
JPI INTENSIFYING SCREENManufacturer
Date Cleared
1996-02-02
(150 days)
Product Code
Regulation Number
892.1960Type
TraditionalPanel
RAReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(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 § 892.9.