XIMATRON IV

K781496 · Siemens Elema AB · KPQ · Sep 14, 1978 · Radiology

Device Facts

Record IDK781496
Device NameXIMATRON IV
ApplicantSiemens Elema AB
Product CodeKPQ · Radiology
Decision DateSep 14, 1978
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.5840
Device ClassClass 2

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Innolitics

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