LogoFDA 510(k) Search
K Number
K093640
Device Name
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
Manufacturer
ELECTRON JSCO.
Date Cleared
2011-04-29

(521 days)

Product Code
IXK
Regulation Number
892.1630
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 892.1630 Electrostatic x-ray imaging system.

(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.