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K Number
K052473
Device Name
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
Manufacturer
INTER MEDICAL MEDIZINTECHNIK GMBH
Date Cleared
2005-10-28

(49 days)

Product Code
IYX
Regulation Number
892.1100
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).