FDA UDI
In Commercial Distribution
🇺🇸 United States
3D SCANNER (TNC)
DI: 05060608880362
·
Model: 1231900Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 3D SCANNER (TNC)
- Primary DI
- 05060608880362
- Version / Model
- 1231900Z
- Catalog Number
- 1231900Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-09
- Public Version
- 1
- Public Version Date
- 2019-10-17
- Public Version Status
- New
- Public Device Record Key
- ad7a5ae0-068f-4585-89a8-db7db57fb956
Device Description
Radiation therapy QA device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B01612300000TZ0 | HIBCC | ||||
| Primary | 05060608880362 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101992 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never store the 3D SCANNER system, associated parts, or accessories inside the treatment room.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store any items in the Water Tank that are not used operationally or are not part of the 3D SCANNER system.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store any radiation sensitive electronic equipment in the 3D Lift storage compartments.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 18.7 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- To maintain mechanical integrity, do not store water in the Water Tank. Ensure that the system is clean and dry before storing.
- Type
- Special Storage Condition, Specify
- Special Conditions
- The 3D SCANNER, 3D MiniLift or 3D Lift, and Automatic Leveling Platform must be stored in an indoor air-conditioned location.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- When measurement is complete, the 3D SCANNER Water Tank can remain attached to the Automatic Leveling Platform and 3D MiniLift or 3D Lift (recommended).
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.