FDA.reportPublic FDA data

Active Breathing Coordinator

Primary DI
05060191071277
Brand
Active Breathing Coordinator
Company
ELEKTA LIMITED
Model
1504204
Device description
Active Breathing Coordinator
Published
2016-12-09
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
K151097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151097000Active Breathing CoordinatorAktina Medical Corporation2015-05-15IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060191071277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060191071277050601910712775060191071277

GMDN Terms#

Term, Definition table
TermDefinition
Real-time position management respiratory gating system, opticalAn assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker.

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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00850065937083eMotusEMPNIA INC.IYE2026-09-21
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00850065937304eMotusEMPNIA INC.IYE2026-09-21