Bravos Afterloader System Transfer Guide Tubes, Length Assessment Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191580 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 Transfer Guide Tubes and Length Assessment Device is a remote-controlled system designed for the precise delivery of radionuclides in radiology procedures. It facilitates the controlled transfer of radioactive sources, ensuring accurate positioning and dose administration during brachytherapy treatments.
This device is supplied as part of a Class II medical system, with components including transfer guide tubes and a length assessment tool for measuring source placement. It is intended for single-use applications in controlled clinical environments, adhering to FDA 510(k) clearance under the Radiology advisory committee. The system is regulated under the MDR and requires proper handling, storage, and compliance with radiation safety protocols.
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 | K191580 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K191580 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 3, 2026