Identifiers
- 510(k) Number
- K212114 FDA 510(k)
- FDA Product Code
- IYE 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)
Elekta Unity is a linear accelerator medical device used in radiation oncology for the treatment of cancer and brain disorders. It integrates magnetic resonance imaging with radiotherapy to enable MR-guided radiation therapy with continuous, anatomy-specific imaging and motion management.
The device is supplied as a reusable system for use in clinical radiation oncology settings. It has received FDA 510(k) clearance under K212114 and is classified as a Class II medical device under regulation number 892.5050, with product code IYE.
Frequently asked questions
What is the Elekta Unity used for?
The Elekta Unity is a linear accelerator medical device used in radiation oncology for the treatment of cancer and brain disorders. It integrates magnetic resonance imaging with radiotherapy to enable MR-guided radiation therapy with continuous, anatomy-specific imaging and motion management.
How is the Elekta Unity supplied and is it reusable?
The Elekta Unity is supplied as a reusable system for use in clinical radiation oncology settings, meaning it is designed for repeated use after appropriate cleaning and maintenance between patient treatments.
What regulatory pathway was used for the Elekta Unity and what is its classification?
The Elekta Unity received FDA 510(k) clearance under K212114 and is classified as a Class II medical device under regulation number 892.5050, with product code IYE.
What is the device name and manufacturer of the Elekta Unity?
The device is named Elekta Unity and is manufactured by Elekta Solutions AB, as stated in the device data.
What does the FDA 510(k) clearance K212114 indicate about the Elekta Unity?
The FDA 510(k) clearance K212114 indicates that the Elekta Unity was found to be substantially equivalent to a legally marketed predicate device, based on a traditional review process, and was cleared for marketing on October 1, 2021.
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: Radiation Oncology & Cancer Care Solutions | Elekta, Elekta - Wikipedia, Elekta Unity MR-Linac | MR-Guided Radiotherapy, Elekta - Elekta Unity
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212114 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Solutions Ab
Sources (1)
- FDA 510(k) K212114 24 fields · synced Sep 19, 2026