EMLA (Elekta Evo) +5 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Elekta Harmony EUDAMED
- Model / Reference
- EMLA EUDAMED1578932 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340201504161 EUDAMED
- Basic UDI-DI
- 073402015BUDI000000003PB EUDAMED
- 510(k) Number
- K252188 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
- EMDN Code
- Z11010102 MEDIUM AND MULTI ENERGY LINEAR ACCELERATORS EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The EMLA series comprises linear accelerators designed for external beam radiotherapy. These devices deliver precise, high-energy photon or electron beams to treat malignant and benign conditions, including cancers and non-cancerous tumors, through stereotactic and conventional radiation therapy techniques. Their modular configurations support advanced treatment modalities such as intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT).
These accelerators are intended for use in radiation oncology departments within hospitals or specialized cancer centers. Supplied as reusable medical devices, they require proper maintenance, calibration, and adherence to manufacturer guidelines for safe operation. The systems are classified as Class II devices under FDA regulations and comply with the EU Medical Device Regulation (MDR). Each model variant (Evo, VersaHD, Harmony Pro, Infinity, Harmony, Synergy) may feature distinct technical specifications or software capabilities, as detailed in the manufacturer’s documentation.
Frequently asked questions
What types of radiation therapy techniques can the EMLA series linear accelerators support, and how do these differ from standard treatments?
The EMLA series linear accelerators are designed to deliver precise, high-energy photon or electron beams for both conventional radiation therapy and advanced techniques. These include intensity-modulated radiation therapy (IMRT), which tailors radiation dose distribution to spare healthy tissue, and volumetric modulated arc therapy (VMAT), where the machine rotates around the patient while adjusting dose rate, beam energy, and gantry speed for optimized treatment. These modalities improve targeting accuracy and reduce side effects compared to traditional fixed-field radiotherapy.
Are the EMLA linear accelerators reusable, and what maintenance requirements should a facility expect?
Yes, the EMLA series linear accelerators are reusable medical devices, requiring regular maintenance, calibration, and adherence to manufacturer guidelines for safe operation. Facilities must establish protocols for servicing, including mechanical, electrical, and software checks, as well as radiation safety compliance. Elekta Solutions AB provides documentation outlining these procedures to ensure optimal performance and longevity.
How does the regulatory pathway for the EMLA series differ between the U.S. and the EU?
In the U.S., the EMLA series holds FDA 510(k) clearance, classified as Class II devices, indicating it is deemed substantially equivalent to a predicate device through a traditional review process. In the EU, compliance is achieved under the EU Medical Device Regulation (MDR), with no explicit mention of CE marking in the provided data—though compliance with MDR is implied. Both pathways ensure adherence to stringent safety and performance standards.
What are the key differences between the EMLA model variants (e.g., Evo, VersaHD, Harmony Pro), and how might a buyer choose between them?
While the exact technical specifications vary by model, the EMLA series includes variants like Evo, VersaHD, Harmony Pro, Infinity, Harmony, and Synergy, each potentially offering distinct technical specifications or software capabilities (e.g., advanced imaging, treatment planning, or automation features). Buyers should consult Elekta’s documentation to compare capabilities such as beam energy ranges, gantry design, or integration with treatment planning systems to select the model best suited for their facility’s workflow and patient volume.
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 | K252188 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Solutions Ab
Sources (2)
- FDA 510(k) K252188 24 fields · synced Oct 6, 2026
- EUDAMED ccbd2456-5c54-4a57-99eb-8ee3a06170e3 61 fields · synced Jul 23, 2026