Interlocked Circular Small Field Collimators, Elekta Integrated
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161984 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)
The Interlocked Circular Small Field Collimators, Elekta Integrated are designed as accessory components for linear accelerator-based radiation therapy systems. These collimators are used to precisely shape and define the radiation field during external beam radiotherapy, enabling targeted treatment of small, irregularly shaped tumor volumes with improved dose conformity and reduced exposure to surrounding healthy tissue.
These collimators are intended for integration with Elekta linear accelerators and are supplied as reusable medical devices. They are classified as Class II devices under FDA regulations and comply with the Medical Device Regulation (MDR) in the EU. The collimators are non-sterile and must be cleaned and maintained according to manufacturer guidelines. They are not MRI-compatible and are supplied in various sizes to accommodate different clinical applications.
Frequently asked questions
Are these collimators compatible with all Elekta linear accelerator models, or are there specific systems they work with?
The Interlocked Circular Small Field Collimators are designed specifically for integration with Elekta linear accelerators, but the exact compatibility depends on the model and configuration of your system. While the device is labeled for use with Elekta accelerators, it is important to verify compatibility with your institution’s specific equipment through Elekta’s technical support or the manufacturer’s guidelines, as not all models may support these collimators.
How should these collimators be cleaned and maintained to ensure proper functionality and longevity?
Since these collimators are reusable and non-sterile, they must be cleaned and maintained according to the manufacturer’s guidelines provided by Aktina Medical Corporation. Proper cleaning protocols are critical to prevent contamination, ensure precision, and maintain the integrity of the device for repeated use in radiation therapy. Always follow the instructions included with the device or consult the manufacturer for specific cleaning agents and procedures.
What sizes or models of these collimators are available, and how do I determine which one is best suited for my clinical needs?
The Interlocked Circular Small Field Collimators come in various sizes to accommodate different clinical applications, particularly for shaping radiation fields during external beam radiotherapy. The exact sizes are not detailed in the provided data, but they are designed for small, irregularly shaped tumor volumes. To determine the best fit for your needs, consult your radiation oncologist or Elekta’s technical documentation, which likely outlines recommended sizes based on tumor geometry and treatment planning requirements.
Can these collimators be used in MRI environments, or are there any restrictions related to imaging compatibility?
No, these collimators are explicitly stated as not MRI-compatible. They are designed solely for use with linear accelerator-based radiation therapy systems and should not be used in MRI environments due to potential interference or safety risks. Always ensure the treatment room and equipment comply with the manufacturer’s guidelines to avoid complications.
What regulatory pathways have these collimators followed, and how does that affect their use in different markets?
The Interlocked Circular Small Field Collimators have undergone FDA 510(k) clearance in the U.S. and comply with the Medical Device Regulation (MDR) in the EU, indicating they meet both regulatory standards for those markets. The FDA classification is Class II, and the device is substantially equivalent to a predicate under the 510(k) pathway. For global use, ensure compliance with local regulations, as additional approvals or certifications may be required depending on the country or region.
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 | K161984 | Class II | Active |
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Manufacturer
- Manufacturer
- Aktina Medical Corporation
Sources (2)
- FDA 510(k) K161984 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026