FDA.reportPublic FDA data

Agility™

Primary DI
05060191071031
Brand
Agility™
Company
ELEKTA LIMITED
Model
1525725
Device description
Agility
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
IYEAccelerator, linear, medical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060191071031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060191071031050601910710315060191071031

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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00850065937304eMotusEMPNIA INC.IYE2026-09-21