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) (10)

Premarket Exempt

Clear

BIONIX RADIATION THERAPY - 00817740020218 Catalog Number : EMRT-8335

Device Description : 2.4MM HEAD ONLY VERSAFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020225 Catalog Number : EMRT-8340

Device Description : 3.2MM HEAD ONLY VERSAFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020232 Catalog Number : EMRT-8345

Device Description : 3.2MM HEAD & SHOULDER SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020249 Catalog Number : EMRT-8350

Device Description : 2.4MM HEAD & SHOULDER VERSAFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020256 Catalog Number : EMRT-8355

Device Description : 3.2MM HEAD & SHOULDER VERSAFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020263 Catalog Number : EMRT-8360

Device Description : 3.2MM HEAD ONLY S-TYPE SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020270 Catalog Number : EMRT-8365

Device Description : 2.4MM HEAD ONLY S-TYPE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020287 Catalog Number : EMRT-8370

Device Description : 3.2MM HEAD ONLY S-TYPE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020294 Catalog Number : EMRT-8375

Device Description : 3.2MM HEAD & SHOULDER S-TYPE SECUREFRAME

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020300 Catalog Number : EMRT-8380

Device Description : 2.4MM HEAD & SHOULDER S-TYPE

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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