SL Series Linear Accelerator (SL 15, 18, 20, 25)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K882231 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 SL Series Linear Accelerator (SL 15, 18, 20, 25) is a Class II medical device classified as an accelerator, linear, medical. Designed for radiotherapy, it delivers high-energy electron and photon beams for cancer treatment, enabling precise tumor targeting and dose delivery in radiology settings.
This device is supplied as a reusable medical system, intended for use in clinical radiation oncology environments. The SL Series models (SL 15, SL 18, SL 20, SL 25) are regulated under FDA 510(k) clearance (K882231) and fall under product code IYE. No sterility or single-use specifications are noted; maintenance and calibration follow manufacturer guidelines. MRI safety and storage conditions are not specified in the regulatory data.
Frequently asked questions
What types of radiation beams does the SL Series Linear Accelerator deliver, and how are they used in cancer treatment?
The SL Series Linear Accelerator delivers high-energy electron and photon beams, which are critical for precision radiotherapy. These beams allow clinicians to target tumors with controlled doses while minimizing exposure to surrounding healthy tissue. The device is specifically designed for use in radiation oncology settings to treat various cancers by precisely delivering radiation to affected areas.
Is the SL Series Linear Accelerator intended for single-use or repeated use in clinical settings?
The SL Series is a reusable medical system, not intended for single-use. It is engineered for long-term clinical use in radiotherapy environments, requiring regular maintenance and calibration as outlined by the manufacturer to ensure accurate and safe operation.
What regulatory pathway was followed for the SL Series Linear Accelerator, and what does this mean for its use?
The SL Series underwent FDA 510(k) clearance (K882231) under the traditional review process, with a determination of substantial equivalence to prior devices. This means the device was evaluated against existing, legally marketed linear accelerators and deemed comparable in safety and effectiveness. Clinicians can rely on this regulatory route as part of its approval for use in radiation oncology settings.
Are there different models in the SL Series, and if so, how do they differ?
Yes, the SL Series includes four models: SL 15, SL 18, SL 20, and SL 25. While the exact technical differences between these models aren’t specified in the regulatory data, they likely vary in specifications such as beam energy, energy range, or other performance characteristics tailored for different clinical needs in radiotherapy. The models are all classified under the same product code (IYE) and regulatory framework.
What are the key considerations for storage and maintenance of the SL Series Linear Accelerator?
The regulatory data does not specify MRI safety or storage conditions for the SL Series. However, as a reusable medical device, it requires adherence to manufacturer guidelines for proper maintenance and calibration to ensure optimal performance and safety. Clinicians should follow Philips Medical Systems’ recommendations for routine upkeep, as these are essential for reliable operation in radiotherapy environments.
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: SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) (K882231) — FDA 510 (k ..., PDF K882231 - Sl Series, Sl 15, 18, 20 & 25 (Modification), SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) 510(k)… - FDA.report, Philips SL Series, SL 15, 18, 20 & 25 (modification), Sl Series Accelerators Sl15, Sl18, Sl20 & Sl25
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882231 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K882231 24 fields · synced Sep 20, 2026