DEVICE: 3D SCANNER (BNC) (B01612300000Z0)
Device Identifier (DI) Information
3D SCANNER (BNC)
12300000Z
Not in Commercial Distribution
12300000Z
SUN NUCLEAR CORP.
12300000Z
Not in Commercial Distribution
12300000Z
SUN NUCLEAR CORP.
Radiation therapy QA device.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| 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 [?] |
|---|---|
| K101992 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: If the 3D SCANNER Water Tank needs transportation independent of the Leveling Platform and 3D MiniLift or 3D Lift, use the four handles on the Lift Ring at the base of the Water Tank for support. |
| Special Storage Condition, Specify: When measurement is complete, the 3D SCANNER Water Tank can remain attached to the Automatic Leveling Platform and 3D MiniLift or 3D Lift (recommended). |
| Special Storage Condition, Specify: When shipping/transporting the 3D SCANNER system between facilities, it is recommended to use the accessory shipping cases for the 3D SCANNER Water Tank, Automatic Leveling Platform, and 3D MiniLift. |
| Special Storage Condition, Specify: Never store the 3D SCANNER system in an area that is under construction. Excessive dust may reduce the precision of the 3D SCANNER motors and mechanical parts. |
| Special Storage Condition, Specify: Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room. |
| Special Storage Condition, Specify: Do not store any items in the Water Tank that are not used operationally or are not part of the 3D SCANNER system. |
| Special Storage Condition, Specify: Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments. |
| Storage Environment Temperature: between 10 and 40 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal |
| Handling Environment Temperature: between -30 and 50 Degrees Celsius |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 18.7 and 106 KiloPascal |
| Special Storage Condition, Specify: Two person lift required. Use proper lifting and handling techniques to prevent injury or equipment damage. Lift the Water Tank using the four lift handles. |
| Special Storage Condition, Specify: Store the 3D SCANNER system 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: For transport and storage within the facility, the 3D SCANNER water tank can remain attached to the 3D MiniLift or 3D Lift as well as the Automatic Leveling Platform. |
| Special Storage Condition, Specify: If the 3D SCANNER, 3D MiniLift, or 3D Lift were shipped in a wood crate, do not re-use the crate for storage or shipping. Accessory shipping cases are available. |
| Special Storage Condition, Specify: Before storing the 3D SCANNER system, place the protective caps on the electrometer FIELD and REF inputs, ensure that all parts are clean and dry, and then place the dust cover over the Water Tank. |
| Special Storage Condition, Specify: To maintain mechanical integrity, do not store water in the Water Tank. Ensure that the system is clean and dry before storing. |
| Special Storage Condition, Specify: The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
30fa2878-d622-4d8f-8778-b5c95e7efc52
June 18, 2019
5
January 14, 2017
June 18, 2019
5
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