FDA.reportPublic FDA data

ARIA Radiation Therapy Management

Primary DI
00856100006004
Brand
ARIA Radiation Therapy Management
Company
Varian Medical Systems Imaging Laboratory GmbH
Model
15.0
Device description
RTM
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K133572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133572000ARIA RADIATION THERAPY MANAGEMENTVarian Medical Systems, Inc.2014-04-04IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856100006004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856100006004008561000060048561000060040856100006004

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment record/verify systemA dedicated information system comprising computers and software intended to reduce human error by monitoring linear accelerator parameters to verify that the proper radiotherapy treatment is being delivered, and to provide a permanent record. It permits a computer verification of all treatment parameters prior to the commencement of a patient's treatment. Patient information, treatment machine parameters and the dose prescription relating to that patient's treatment are entered into a patient file and stored. Comparisons are made by the record and verify system and system interlocks to ensure that treatment is not permitted if any parameters are outside the predetermined tolerances.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482243784
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856100006011Smart Segmentation - Knowledge Based Contouring15.02016-09-16

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Primary DI, Brand, Company table
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