INTRAOP MEDICAL CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Radiation Therapy, Charged-Particle, Medical (LHN) (1)

Premarket Exempt

Clear

MOBETRON - 00861396000308 Catalog Number :

Device Description : The MOBETRON is intended for use as an Electron Beam source inside an Operating The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72

Device Class : 2

Duns Number: 079168716

Premarket Exempt : No

Product Code : LHN

Prescription Use : No

Device Count : 1

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