DEVICE: 3D MiniLift (05060608880324)
Device Identifier (DI) Information
3D MiniLift
1231600Z
In Commercial Distribution
1230000-3Z
SUN NUCLEAR CORP.
1231600Z
In Commercial Distribution
1230000-3Z
SUN NUCLEAR CORP.
Accessory to the 3D SCANNER 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: Fingers can be pinched when changing the 3D MiniLift leg positions. Keep hands clear of the Leg joints and Frame when changing the Leg positions. |
| Special Storage Condition, Specify: Remove all water from the 3D SCANNER before changing the 3D MiniLift Leg positions. |
| 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. |
| 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: 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: 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: A two-person lift is required for the 3D MiniLift Frame and Lift Subassembly. Use proper lifting techniques to avoid injury. |
| 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 |
| Special Storage Condition, Specify: Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments. |
| Special Storage Condition, Specify: Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room. |
| 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: 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: When measurement is complete, the 3D SCANNER Water Tank can remain attached to the Automatic Leveling Platform and 3D MiniLift or 3D Lift (recommended). |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
4e818222-51bd-460c-8c57-87526de5c07d
June 05, 2019
1
May 28, 2019
June 05, 2019
1
May 28, 2019
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