FDA.reportPublic FDA data

BIONIX RADIATION THERAPY

Primary DI
00817740020447
Brand
BIONIX RADIATION THERAPY
Company
Bionix Radiation Therapy, LLC
Model
HNRT-5039
Catalog number
HNRT-5039
Device description
SUPRONE PLUS HEAD & NECK BOARD
Published
2017-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050701000THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010Bionix Development Corp.2005-04-01IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817740020447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817740020447008177400204478177400204470817740020447

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)624-6649xxx@xxx.xxx

Regulatory Flags#

DUNS number
080397923
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817740020027BIONIX RADIATION THERAPYBKRT-5037BKRT-50372017-04-25
00817740020034BIONIX RADIATION THERAPYBKRT-5036BKRT-50362017-04-25
00817740020041BIONIX RADIATION THERAPYBKRT-5036BKRT-50362017-04-25
00817740020058BIONIX RADIATION THERAPYBKRT-5038BKRT-50382017-04-25
00817740020065BIONIX RADIATION THERAPYBKRT-5038BKRT-50382017-04-25
00817740020072BIONIX RADIATION THERAPYEMRT-8300EMRT-83002017-04-25
00817740020157BIONIX RADIATION THERAPYEMRT-8305EMRT-83052017-04-25
00817740020164BIONIX RADIATION THERAPYEMRT-8310EMRT-83102017-04-25
00817740020171BIONIX RADIATION THERAPYEMRT-8315EMRT-83152017-04-25
00817740020188BIONIX RADIATION THERAPYEMRT-8320EMRT-83202017-04-25
00817740020195BIONIX RADIATION THERAPYEMRT-8325EMRT-83252017-04-25
00817740020201BIONIX RADIATION THERAPYEMRT-8330EMRT-83302017-04-25
00817740020218BIONIX RADIATION THERAPYEMRT-8335EMRT-83352017-04-25
00817740020225BIONIX RADIATION THERAPYEMRT-8340EMRT-83402017-04-25
00817740020232BIONIX RADIATION THERAPYEMRT-8345EMRT-83452017-04-25
00817740020249BIONIX RADIATION THERAPYEMRT-8350EMRT-83502017-04-25
00817740020256BIONIX RADIATION THERAPYEMRT-8355EMRT-83552017-04-25
00817740020263BIONIX RADIATION THERAPYEMRT-8360EMRT-83602017-04-25
00817740020270BIONIX RADIATION THERAPYEMRT-8365EMRT-83652017-04-25
00817740020287BIONIX RADIATION THERAPYEMRT-8370EMRT-83702017-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22