Identifiers
- 510(k) Number
- K112981 FDA 510(k)
- FDA Product Code
- LHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sun 125C Ionization Chamber is a thimble-type ionization chamber designed for radiation dosimetry measurements. It falls under the category of charged-particle medical radiation devices, specifically for use in scanning, field, and reference dosimetry. The device measures ionizing radiation by generating a current in a 0.125 cc ionization volume when exposed to radiation, enabling precise dose assessment in clinical settings. Its construction includes a fully-guarded, waterproof design to ensure accuracy in high-dose gradient regions.
This device is supplied as a reusable medical instrument and is intended for use in radiation therapy quality assurance. It is not classified as single-use and requires proper handling and maintenance to ensure functionality. The Sun 125C Ionization Chamber is authorized under FDA 510(k) clearance (K112981) and adheres to regulatory standards outlined in 21 CFR 892.5050. It is designed for use in radiology environments and must be stored and calibrated according to manufacturer guidelines to maintain performance integrity.
Frequently asked questions
What is the Sun 125C Ionization Chamber used for?
The Sun 125C Ionization Chamber is specifically designed for radiation dosimetry measurements in clinical environments. It is used in scanning, field, and reference dosimetry to measure ionizing radiation by generating a current in its 0.125 cc ionization volume when exposed to radiation. This allows for precise dose assessment, ensuring accuracy in high-dose gradient regions, particularly in radiation therapy quality assurance.
Is the Sun 125C Ionization Chamber reusable or single-use?
The Sun 125C Ionization Chamber is a reusable medical instrument. It is not intended for single-use and requires proper handling, maintenance, and calibration to ensure continued functionality and accuracy in radiation therapy applications.
What are the key features of the Sun 125C Ionization Chamber’s construction?
The Sun 125C Ionization Chamber features a fully-guarded and waterproof design. This construction ensures that it can operate accurately even in high-dose gradient regions, minimizing environmental interference and maintaining precision in clinical dosimetry measurements.
How should the Sun 125C Ionization Chamber be stored?
The Sun 125C Ionization Chamber must be stored according to the manufacturer’s guidelines to maintain its performance integrity. Proper storage conditions help preserve its functionality, calibration accuracy, and longevity, particularly in radiology environments where it is used for critical dose assessments.
What regulatory standards does the Sun 125C Ionization Chamber comply with?
The Sun 125C Ionization Chamber is authorized under FDA 510(k) clearance (K112981) and adheres to regulatory standards outlined in 21 CFR 892.5050. This ensures it meets the necessary requirements for use in radiation therapy and dosimetry applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SNC125c™, SNC350p™, & SNC600c™ - Sun Nuclear, PDF Enhanced Penumbra Without, SUN 125C IONIZATION CHAMBER (K112981) — FDA 510(k) | Innolitics, SNC125c™ - POCL Medical Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112981 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sun Nuclear Corp.
Sources (1)
- FDA 510(k) K112981 24 fields · synced Oct 1, 2026