DEVICE: WaterProof PROFILER (B01612300009Z0)
Device Identifier (DI) Information
WaterProof PROFILER
12300009Z
In Commercial Distribution
12300009Z
SUN NUCLEAR CORP.
12300009Z
In Commercial Distribution
12300009Z
SUN NUCLEAR CORP.
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
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| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 38399 | 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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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IYE | Accelerator, Linear, Medical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K142431 | 000 |
Sterilization
Storage and Handling
[?]| 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 |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
530c53f6-6d2e-4cb5-b12e-9ef5f6e13f10
July 06, 2018
3
January 14, 2017
July 06, 2018
3
January 14, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined