DEVICE: WaterProof PROFILER (B01612300009Z0)

Device Identifier (DI) Information

WaterProof PROFILER
12300009Z
In Commercial Distribution
12300009Z
SUN NUCLEAR CORP.
B01612300009Z0
HIBCC

1
122240021 *Terms of Use
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Accelerator system quality assurance device An 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.
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FDA Product Code

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Product Code Product Code Name
IYE Accelerator, Linear, Medical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142431 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not store the instrument in the treatment room.
Special Storage Condition, Specify: Never leave the instrument on the couch during delivery system warm up.
Special Storage Condition, Specify: Never expose the device's electronic circuits to the direct radiation beam.
Special Storage Condition, Specify: Store device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify: Ensure that all device parts, including cable and connector, are clean and dry before placing in storage case. Dry with a soft cloth. Never use abrasive cleaners.
Special Storage Condition, Specify: If connector is accidentally immersed in water, allow to dry completely before connecting to 3D SCANNER.
Special Storage Condition, Specify: Do not keep device in water for longer than 24 hours.
Special Storage Condition, Specify: For transport and storage within the facility, the device can remain attached to the Water Tank, but it is recommended to store the device in its case when not in use.
Handling Environment Atmospheric Pressure: between 18.7 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

530c53f6-6d2e-4cb5-b12e-9ef5f6e13f10
July 06, 2018
3
January 14, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
Yes
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Customer Contact

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No Customer Contact currently defined
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