FDA.reportPublic FDA data

BIONIX RADIATION THERAPY

Primary DI
00817740020577
Brand
BIONIX RADIATION THERAPY
Company
Bionix Radiation Therapy, LLC
Model
4500-00-02
Catalog number
4500-00-02
Device description
Gen 2 SBRT POSITIONING SYSTEM
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
K100691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100691000OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500Bionix Development Corp.2010-05-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817740020577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817740020577008177400205778177400205770817740020577

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment planning positioning kitA collection of non-sterile devices intended to assist collection of diagnostic magnetic resonance imaging (MRI) images to be used as part of radiation therapy treatment planning. It includes multiple devices intended to ensure adequate positioning and/or immobilization of the patient during MRI imaging (e.g., radiological whole-body positioning frame/board, laser patient positioning system), and may include imaging supportive/reference devices (e.g., MRI phantom).

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

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Primary DI, Brand, Company table
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00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
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