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 - 00817740020515 Catalog Number : HNRT-7040-02

Device Description : VERSABOARD ULTRA GEN 2

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020522 Catalog Number : HNRT-7664

Device Description : CARBON FIBER 45 DEGREE ATTACHMENT

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020539 Catalog Number : 6030-30

Device Description : COMFORT HOLD FOOT POSITIONER

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020546 Catalog Number : 6030-50

Device Description : COMFORT HOLD THIGH POSITIONER

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020553 Catalog Number : PPRT-5106

Device Description : PELVIS BELLY: LARGE STOMACH CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020560 Catalog Number : PPRT-5108

Device Description : PELVIS BELLY: ANKLE CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020577 Catalog Number : 4500-00-02

Device Description : Gen 2 SBRT POSITIONING SYSTEM

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020584 Catalog Number : SVRT-6017

Device Description : T-FORM SECUREVAC BOX ADAPTOR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020591 Catalog Number : SVRT-7017

Device Description : SECUREVAC BOX

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740020607 Catalog Number : SVRT-7106

Device Description : SECUREVAC HOSE ADAPTOR

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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