Bravos Afterloader System, Transfer Guide Tubes and Length Assessment Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221797 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bravos Afterloader System is a System, Applicator, Radionuclide, Remote-Controlled designed for brachytherapy procedures. It delivers radioactive sources to precise locations within the body for targeted radiation therapy, ensuring controlled and accurate dose administration during treatments such as prostate, gynecological, or breast cancer interventions.
This system is supplied as a reusable medical device, intended for use in radiology settings under sterile conditions. It includes transfer guide tubes and a length assessment device, with multiple model-specific configurations (e.g., reference codes 1000523114, 3000270450). Authorized under FDA 510K and MDR, it adheres to regulatory standards for Class II devices (892.5700) and is compatible with MRI environments as specified in its design. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
Is the Bravos Afterloader System designed for single-use or can it be reused in multiple procedures?
The Bravos Afterloader System is explicitly described as a reusable medical device. It is intended for use in radiology settings under sterile conditions, meaning it must be properly cleaned, maintained, and sterilized between procedures to ensure safety and functionality. The manufacturer provides guidelines for storage and handling to preserve sterility and performance.
What types of cancer treatments is the Bravos Afterloader System primarily used for, and how does it work?
The Bravos Afterloader System is designed for brachytherapy procedures, delivering radioactive sources to precise locations within the body for targeted radiation therapy. It is specifically mentioned for treatments like prostate, gynecological, or breast cancer interventions, ensuring controlled and accurate dose administration during the procedure. The system uses remote-controlled applicators to place radiation sources directly into the treatment area.
Does the Bravos Afterloader System come with accessories, and if so, what are they used for?
Yes, the Bravos Afterloader System includes transfer guide tubes and a length assessment device as part of its configuration. The transfer guide tubes help position radioactive sources accurately during brachytherapy, while the length assessment device ensures proper sizing and alignment for the procedure. These components work together to enhance precision and safety in radiation delivery.
Are there multiple models or configurations available for the Bravos Afterloader System, and how would I identify them?
Yes, the Bravos Afterloader System offers multiple model-specific configurations, each identified by unique reference codes (e.g., 1000523114, 3000270450). These codes correspond to different setups or accessories within the system, allowing for flexibility in clinical applications. You can identify the correct model by checking the manufacturer’s documentation or labeling on the device packaging.
Can the Bravos Afterloader System be used in an MRI environment, and what considerations should be taken into account?
The Bravos Afterloader System is compatible with MRI environments, as specified in its design. However, proper handling and adherence to manufacturer guidelines are critical to ensure safety and functionality. This includes following storage and operational protocols to maintain sterility and avoid interference with MRI procedures. Always consult the manufacturer’s instructions for specific MRI-related precautions.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221797 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K221797 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026