FDA.reportPublic FDA data

EZFluence

Primary DI
00860001672718
Brand
EZFluence
Company
Radformation, Inc
Model
2.3
Device description
EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields.
Published
2021-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171352000EZFluenceRadformation, Inc.2017-12-01IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001672718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001672718008600016727188600016727180860001672718

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080444608
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072631097AutoContourVersion 2.82026-08-25
00850072631028ClearCheckVersion 2.72026-05-04
00850072631042AutoContourVersion 2.72026-03-30
00850072631004ClearCalcVersion 2.72026-03-13
00850072631035ChartCheckRADCH V1.62026-03-13
00850072631059ChartCheckVersion 1.72026-03-13
00860001672770ClearCheck V2RADCC V22026-03-13
00860001672787ClearCalcRADCA V2.62026-03-13
00860001672794EZFluenceVersion 2.52026-03-13
00860001672725ClearCalc2.02021-10-11
00860001672732AutoContour2.02021-10-11
00860001672701ClearCheck2.02021-10-04
00860001672749ChartCheck1.22021-10-04

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Primary DI, Brand, Company table
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