BIONIX RADIATION THERAPY, LLC

BIONIX RADIATION THERAPY, LLC

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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

Accelerator, linear, medical (IYE) (2)

Premarket Exempt

No

Clear

BIONIX RADIATION THERAPY - 00817740021352 Catalog Number : 4500-100A

Device Description : SBRT Respiratory Plate- Arch

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 08177400245002 Catalog Number : SBRT-4500

Device Description : OMNI V SBRT POSITIONING SYSTEM

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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