K Number
K954998Device Name
LILY DARK VIEWERManufacturer
Date Cleared
1996-01-29
(89 days)
Product Code
Regulation Number
892.1890Type
TraditionalPanel
RAReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 892.1890 Radiographic film illuminator.
(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(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.