FOCUS RTP

K915691 · Computerized Medical Systems, Inc. · MUJ · Feb 16, 1995 · Radiology

Device Facts

Record IDK915691
Device NameFOCUS RTP
ApplicantComputerized Medical Systems, Inc.
Product CodeMUJ · Radiology
Decision DateFeb 16, 1995
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.5050
Device ClassClass 2

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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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