DEVICE: SNC350p (TNC) (05060608880232)
Device Identifier (DI) Information
SNC350p (TNC)
1045400Z
In Commercial Distribution
1045000-1Z
SUN NUCLEAR CORP.
1045400Z
In Commercial Distribution
1045000-1Z
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? |
|---|---|---|---|---|
| 38336 | Solid-state-semiconductor radiation measuring probe |
A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K112981 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case. |
| Handling Environment Temperature: between -30 and 50 Degrees Celsius |
| Storage Environment Temperature: between 10 and 40 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 18.7 and 106 KiloPascal |
| Special Storage Condition, Specify: Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case. |
| Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal |
| Special Storage Condition, Specify: Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area. |
| Special Storage Condition, Specify: The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects. |
| Special Storage Condition, Specify: Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum. |
| Special Storage Condition, Specify: If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e4be263a-5ddc-411c-81d7-b32855fb57f1
July 30, 2020
1
July 22, 2020
July 30, 2020
1
July 22, 2020
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