FDA.reportPublic FDA data

Varian Acuity with Conebeam Computed Tomography

Primary DI
00856545006010
Brand
Varian Acuity with Conebeam Computed Tomography
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
2.1
Catalog number
TM64001000
Published
2020-06-04
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
00856545006010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856545006010008565450060108565450060100856545006010

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.

Sterilization Methods#

Method table
Method

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
00856100006493Respiratory Gating for Scanners2.12026-06-05
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmGM11014100GM110141002026-06-02
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856545006003Acuity iX Radiation Therapy Simulation SystemVARIAN MEDICAL SYSTEMS, INC.KPQ2020-09-20
07540180000238Clarity®Elekta Solutions ABKPQ2020-06-19
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