Apex™

Primary DI
05060191071215
Brand
Apex™
Company
ELEKTA LIMITED
Model
1526774
Device description
Apex
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXIBlock, beam-shaping, radiation therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXIBlock, Beam-Shaping, Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111676000APEXElekta Limited2011-09-30IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060191071215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060191071215050601910712155060191071215

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-aperture-control accelerator system collimatorA motorized, radiation beam-limiting device that is a component of a therapeutic accelerator system and composed of highly-attenuating materials or alloys [e.g., lead (Pb), tungsten (W)] with jaw or leaf positioning functions that are computer-controlled. Mounted at the beam exit port, it is used to adjust the shape of the radiation beam to the body area targeted for treatment. It provides patient protection by limiting or eliminating radiation delivery to non-target body areas during treatment. A light localizer is typically included in the design of the device to indicate the location of the radiation beam and assist in the positioning of patients for treatment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)693-5358systems.support.na@elekta.com

Regulatory Flags#

DUNS number
525557559
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060191071420Elekta Unity10590732019-04-30
05060191071437Elekta Unity10651202019-04-30
05060191070829NA15253252016-09-24
05060191070836NA15253262016-09-24
05060191070843NA15253302016-09-24
05060191070850NA15253312016-09-24
05060191070867NA15253322016-09-24
05060191070874NA15253332016-09-24
05060191070881NA15253372016-09-24
05060191070898NA15253382016-09-24
05060191070904NA15253392016-09-24
05060191070911NA15253402016-09-24
05060191070928NA15253412016-09-24
05060191070935NA15253422016-09-24
05060191070942NA15253842016-09-24
05060191070959NA15253852016-09-24
05060191070966NA15253862016-09-24
05060191070973NA15253872016-09-24
05060191070980NA15253432016-09-24
05060191070997NA15253442016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00851147007137decimal Bolus (FlexiBol)DECIMAL, INC.IXI2022-12-01
B365112680Universal Leveling Template, Set of FiveAktina Corp.IXI2021-05-21
B365112690Universal Leveling Plate System, Elekta CompatibleAktina Corp.IXI2021-05-21
B365530460Hot Wire CutterAktina Corp.IXI2021-05-21
B36511268010Universal Leveling Template, 25X25Aktina Corp.IXI2016-09-27
B36511268020Universal Leveling Template, 20X20Aktina Corp.IXI2016-09-27
B36511268030Universal Leveling Template, 14X14Aktina Corp.IXI2016-09-27
B36511268040Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-27
B36511268050Universal Leveling Template, 6X6Aktina Corp.IXI2016-09-24
B36511269010Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-24
B36511269020Universal Leveling Template, 6X10Aktina Corp.IXI2016-09-24
B365112700Electron Beam Shaping System, Elekta Compatible, Full SystemAktina Corp.IXI2016-09-24
B365112850Low Energy Beam Block SetAktina Corp.IXI2016-09-24
B365112900High Energy Beam Block SetAktina Corp.IXI2016-09-24
B365524850Electron Beam Shaping Full System, Siemens 95 cm, Full SystemAktina Corp.IXI2016-09-24
B365526260E-Beam Shaping SystemAktina Corp.IXI2016-09-24
B365534180Beam Block Set, Low EnergyAktina Corp.IXI2016-09-24
B365534260Beam Block Set, High EnergyAktina Corp.IXI2016-09-24
00851147007014.decimal Proton Range CompensatorDECIMAL, INC.IXI2016-09-24
00851147007021.decimal Electron BolusDECIMAL, INC.IXI2016-09-24
00851147007038.decimal Electron ApertureDECIMAL, INC.IXI2016-09-24
00851147007045.decimal Photon BlockDECIMAL, INC.IXI2016-09-24
00851147007052.decimal Photon CompensatorDECIMAL, INC.IXI2016-09-24
00851147007007.decimal Proton ApertureDECIMAL, INC.IXI2016-09-23