FDA.reportPublic FDA data

ARIA Radiation Therapy Management Software

Primary DI
00856100006066
Brand
ARIA Radiation Therapy Management Software
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
13.6
Published
2020-07-06
Public version status
New
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
K173838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173838000ARIA Radiation Therapy ManagementVarian Medical Systems, Inc.2018-01-17IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856100006066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856100006066008561000060668561000060660856100006066

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
009120817
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029699Assembly module, CT/ MRGM11012910GM110129102025-05-16
00816389029743Retraction Nut CT/MRGM11012960GM110129602025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorGM11010740GM110107402024-11-19
00850800006074Vitesse5.0Vitesse 5.02024-11-01
00816389020245Crook Prostate Template for 2.0 mm needlesGM11012230GM110122302024-02-19
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointGM11009580GM110095802023-05-05
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointGM11009550GM110095502023-04-28
008105630220322.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
008105630220492.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
008105630220562.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
008105630220632.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmGM11013240GM110132402019-11-06
00816389021242Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry)AL13030001AL130300012016-09-19
00816389021297X-ray marker wire, 160 cm x 0.6, channel 1AL13116000AL131160002016-09-19
00816389021310X-ray marker wire, 160 cm x 0.6, channel 3AL13118000AL131180002016-09-19
00816389021747Central clamping mechanismGM11000860GM110008602016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmGM11000890GM110008902016-09-23
00816389021792Colpostats for 20mm spread, pairGM11000910GM110009102016-09-19

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00841439115343MultiFix Indexing PostQfixIYE2026-06-04
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