Alderson Brest Dosimetry System
by Radiology Support Devices, Inc.
510(k) K946074
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946074 | Date21 Dec 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Alderson Brest Dosimetry System is a dosimetry phantom designed for measuring and evaluating radiation dose distribution in breast tissue during radiotherapy. It serves as a standardized model to assess dose accuracy, uniformity, and treatment planning for breast cancer radiation therapy, ensuring consistent and reliable dose delivery to patients.
This system is intended for use in radiation oncology departments and research settings, where it is employed to validate and calibrate linear accelerator-based treatment planning systems. Supplied as a reusable device, it requires proper cleaning and maintenance to preserve accuracy. The system is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K946074) for substantial equivalence. It is not intended for direct patient use but as a quality assurance tool in clinical and research environments.
Questions
AI-generated answers, 1 Oct 2026
What is the Alderson Brest Dosimetry System used for?
The Alderson Brest Dosimetry System is a dosimetry phantom designed specifically for measuring and evaluating radiation dose distribution in breast tissue during radiotherapy. It helps radiation oncology departments and research settings validate and calibrate linear accelerator-based treatment planning systems, ensuring consistent and accurate dose delivery for breast cancer patients. By simulating breast tissue, it allows clinicians to assess dose accuracy, uniformity, and treatment planning before patient treatment.
How is the Alderson Brest Dosimetry System supplied and maintained?
The system is supplied as a reusable medical device. To preserve its accuracy and functionality, it requires proper cleaning and maintenance as outlined in the manufacturer’s instructions. Regular upkeep is essential because any contamination or damage could compromise the phantom’s ability to provide reliable dose measurements, potentially affecting treatment planning and patient safety.
Is the Alderson Brest Dosimetry System intended for direct patient use?
No, the Alderson Brest Dosimetry System is not intended for direct patient use. Instead, it serves as a quality assurance tool in clinical and research environments. Its purpose is to validate and calibrate radiotherapy equipment and treatment planning systems, ensuring they deliver the intended dose accurately before being applied to patients. This helps minimize errors in dose delivery during actual breast cancer treatments.
What regulatory clearance does the Alderson Brest Dosimetry System hold?
The Alderson Brest Dosimetry System holds an FDA 510(k) clearance (K946074) under the substantial equivalence pathway, confirming it meets regulatory standards for Class II medical devices. This clearance was granted by the FDA’s Radiology Advisory Committee, validating its use as a dosimetry phantom for radiation therapy quality assurance. The system is classified under product code IYE and regulation number 892.5050.
Can this system be used with multiple types of linear accelerators?
The Alderson Brest Dosimetry System is designed to work with linear accelerators commonly used in radiotherapy. While the provided data lists multiple FEI numbers associated with linear accelerators, the system’s primary function remains consistent across these devices: validating dose distribution accuracy for breast tissue treatments. Compatibility depends on adherence to the manufacturer’s guidelines for setup and calibration, ensuring accurate phantom-to-machine integration.