FDA.reportPublic FDA data

Integrity™

Primary DI
05060191071079
Brand
Integrity™
Company
ELEKTA LIMITED
Model
1526773
Device description
Integrity
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123808000AGILITYElekta , Ltd.2013-04-04IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060191071079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060191071079050601910710795060191071079

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
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00850065937120eMotusEMPNIA INC.IYE2026-09-21
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00850065937151eMotusEMPNIA INC.IYE2026-09-21
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00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21
00850065937229eMotusEMPNIA INC.IYE2026-09-21
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00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21