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 - 00817740021246 Catalog Number : SVRT-7134

Device Description : 80 CM X 150 CM 70L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021260 Catalog Number : SVRT-7630

Device Description : 115CM X 114CM 25 L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021277 Catalog Number : SVRT-7635

Device Description : 115CM X 114CM 35 L FILL SECUREVAC CUSHION

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021284 Catalog Number : 4500-10-02

Device Description : SBRT Base

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021291 Catalog Number : RT-4601

Device Description : SBRT Respiratory Belt

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021307 Catalog Number : 7528-00-02

Device Description : SBRT Upper Arm Support

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021314 Catalog Number : 4500-30-02

Device Description : SBRT Short Arch

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021321 Catalog Number : 4500-40-02

Device Description : SBRT Tall Arch

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021338 Catalog Number : 4500-20-02

Device Description : SBRT Thigh and Foot Assembly

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

BIONIX RADIATION THERAPY - 00817740021345 Catalog Number : RT-4650

Device Description : SBRT Thigh Strap

Device Class : 2

Duns Number: 080397923

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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