Acuity iX Radiation Therapy Simulation System

Primary DI
00856545006003
Brand
Acuity iX Radiation Therapy Simulation System
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
15.0
Catalog number
TM60010004
Published
2020-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPQSystem, simulation, radiation therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPQSystem, Simulation, Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033339000ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHYVarian Medical Systems, Inc.2003-12-30KPQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856545006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856545006003008565450060038565450060030856545006003

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy simulation systemAn assembly of diagnostic and radiation therapy devices comprising a radiation therapy simulation system intended for radiation therapy treatment planning applications. It is configured as a diagnostic x-ray system, e.g., fluoroscopic, planar, computed tomography (CT) with associated hardware and software. It is used to localize the field volume to be exposed during radiation therapy and to confirm the position and size of the therapeutic irradiation field produced by a specific set of treatment parameters that have been developed. A radiation therapy treatment planning system (RTTPS) will typically interface to receive the parameters being measured for further use in treatment calculations.

Regulatory Flags#

DUNS number
009120817
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileGM11003800GM110038002016-09-23
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleGM11003270GM110032702021-02-02
00816389022188Flexible probe, 2.8 mm diameter x 320 mmGM11002280GM110022802016-09-22
00816389022195Mould probe, ø 1.8 diameter x 320 mm, with mandrinGM11002290GM110022902016-09-19
00816389022478Mandrin for 320mm lengthGM11003100GM110031002016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22
00816389022935Catheter flap 200 mm x 290 mm x 10 mm, 40 channelsGM11003910GM110039102016-09-23
00816389024243Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needlesGM11007560GM110075602016-09-22
00816389024250Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needlesGM11007570GM110075702016-09-18
00816389024267Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needlesGM11007580GM110075802016-09-19
00816389025615Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrinGM11010750GM110107502016-09-22
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540180000238Clarity®Elekta Solutions ABKPQ2020-06-19
00856545006010Varian Acuity with Conebeam Computed TomographyVARIAN MEDICAL SYSTEMS, INC.KPQ2020-06-04
07540180000221Clarity®Elekta Solutions ABKPQ2020-05-22
07540180000214Clarity®Elekta Solutions ABKPQ2019-03-27
07540180000207Clarity®Elekta LtdKPQ2018-11-19
00815212022012IZ PortsIzi Medical Products, LLCKPQ2017-02-08
00815212022050ShadowForm MarkerIzi Medical Products, LLCKPQ2017-02-07
00815212022067ShadowForm markerIzi Medical Products, LLCKPQ2017-02-07
00815212022074ShadowForm MarkerIzi Medical Products, LLCKPQ2017-02-07
00815212022111IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022128IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022135IZ PortsIzi Medical Products, LLCKPQ2017-02-02
00815212022142IZ PortsIzi Medical Products, LLCKPQ2017-02-02
07540180000184Clarity®Elekta LtdKPQ2017-01-10
00815212021695ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021701ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021718ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021725ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021732ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
00815212021749ShadowForm MarkerIzi Medical Products, LLCKPQ2016-11-17
07540180000016Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000023Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000030Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000047Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000054Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000061Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000078Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000085Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000092Clarity®Elekta Solutions ABKPQ2016-09-23
07540180000108Clarity®Elekta Solutions ABKPQ2016-09-23