Modified Sl-Series Linear Accelerators
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K883067 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 Modified Sl-Series Linear Accelerators is a medical device classified as an Accelerator, Linear, Medical. It is designed to accelerate charged particles, such as electrons, to produce high-energy beams for medical applications. The device is substantially equivalent to other linear accelerators and is used in the field of radiology.
The Modified Sl-Series Linear Accelerators is supplied by Philips Medical Systems, Inc. and has been cleared by the FDA under the 510(k) clearance process, with the clearance number K883067. The device is classified as a Class II medical device under the regulation number 892.5050, with a product code of IYE. It is intended for use in a medical setting, specifically in the field of radiology.
Frequently asked questions
What is the Modified SL-Series Linear Accelerators used for?
The Modified SL-Series Linear Accelerators is designed to accelerate charged particles, such as electrons, to produce high-energy beams for medical applications, specifically in the field of radiology, as stated in its description and intended use.
How is the Modified SL-Series Linear Accelerators supplied and cleared for use?
The device is supplied by Philips Medical Systems, Inc. and has been cleared by the FDA under the 510(k) clearance process with clearance number K883067, making it substantially equivalent to other legally marketed linear accelerators.
What regulatory classification and product code apply to the Modified SL-Series Linear Accelerators?
The Modified SL-Series Linear Accelerators is classified as a Class II medical device under regulation number 892.5050 and has the product code IYE, as specified in the device data.
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: MODIFIED SL-SERIES LINEAR ACCELERATORS (K883067) — FDA 510(k) | Innolitics, Philips Modified SL-Series Linear Accelerators - allmed.wiki, PDF K883067 - Modified Sl-series Linear Accelerators, MODIFIED SL-SERIES LINEAR ACCELERATORS 510(k) K883067 - fda.report, Philips SL Series, SL 15, 18, 20 & 25 (modification)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883067 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K883067 24 fields · synced Sep 21, 2026