FDA.reportPublic FDA data

Electron Energy Verification Wedge

Primary DI
B016117081Z0
Brand
Electron Energy Verification Wedge
Company
SUN NUCLEAR CORP.
Model
117081Z
Catalog number
117081Z
Device description
Accessory to the Model 1174 PROFILER 2.
Published
2017-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K063021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063021000PROFILER 2Sun Nuclear Corp.2006-11-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B016117081Z0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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