FDA.reportPublic FDA data

SRS MapCHECK

Primary DI
B01611790000Z0
Brand
SRS MapCHECK
Company
SUN NUCLEAR CORP.
Model
11790000Z
Catalog number
11790000Z
Device description
Radiation therapy QA device.
Published
2018-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K131466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131466000MAPCHECK2, ARCCHECKSun Nuclear Corporation2013-08-20IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01611790000Z0PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify00Do not store the instrument in the treatment room.
Special Storage Condition, Specify00Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.

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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Primary DI, Brand, Model table
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05060608881123SunSCAN 3D12341234900Z2023-06-08
05060608881130SunSCAN 3D12351235900Z2023-06-08
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