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

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