REFLEXION MEDICAL, INC.

Address:25881 Industrial Blvd,Hayward,CA,94545,US

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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

Accelerator, Linear, Medical (IYE) (1) System, Planning, Radiation Therapy Treatment (MUJ) (1)

Premarket Exempt

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Reflexion Medical Radiotherapy System - 00860003983805 Catalog Number :

Device Description : The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy syste The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable ofdelivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice widthchoices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileafcollimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. Itcan achieve a nominal dose rate of 850 cGy/min.

Device Class : 2

Duns Number: 831659169

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : Yes

Device Count : 1

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