Akesis Galaxy
FDA 510(k)Class II (US FDA 510(k))
by Akesis, Inc.
Identifiers
- 510(k) Number
- K190844 FDA 510(k)
- FDA Product Code
- IWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5750 FDA 510(k)
- Regulation Number
- 892.5750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Akesis Galaxy is a rotational gamma radiosurgery system designed for radiation therapy. It delivers precise, high-dose radiation to targeted areas using radionuclide-based technology, enabling conformal dose distribution for stereotactic radiosurgery (SRS) and radiotherapy applications in radiology settings.
This device is intended for use in clinical radiation oncology environments and is supplied as a reusable system. It operates under FDA clearance via a 510(k) submission (K190844) and adheres to regulatory standards for radiation therapy systems (regulation number 892.5750). The system incorporates multiple radionuclide sources for rotational delivery, ensuring flexibility in treatment planning and delivery.
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: Akesis - Innovating radiation medicine, Akesis Galaxy RTi - Innovating radiation medicine, UH Akesis collaboration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190844 | Class II | Active |
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Manufacturer
- Manufacturer
- Akesis, Inc.
Sources (1)
- FDA 510(k) K190844 24 fields · synced Sep 19, 2026