Identifiers
- 510(k) Number
- K200282 FDA 510(k)
- FDA Product Code
- LHN 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 Orfit Aerial Couchtop is a medical charged-particle radiation therapy system. It is classified as a Class II device under regulation number 892.5050 and product code LHN.
The device received FDA 510(k) clearance (K200282) on April 8, 2020, following a traditional review process. It is manufactured by Orfit Industries NV located in Wijnegem, Belgium.
Frequently asked questions
What is the Orfit Aerial Couchtop used for?
The Orfit Aerial Couchtop is a medical charged-particle radiation therapy system designed to support patient positioning during radiation therapy procedures involving charged particles, such as proton or ion beam therapy, enabling precise delivery of treatment.
How is the Orfit Aerial Couchtop supplied and is it reusable?
The Orfit Aerial Couchtop is supplied as a reusable system component intended for multiple uses in clinical settings; it is not a single-use device and requires proper cleaning and maintenance between uses according to manufacturer guidelines.
What regulatory pathway was used for the Orfit Aerial Couchtop?
The Orfit Aerial Couchtop received FDA 510(k) clearance through a traditional review process under submission number K200282, demonstrating substantial equivalence to a legally marketed predicate device.
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: Couch Tops | Orfit, K200282 - Orfit Aerial Couchtop - Radiology, Orfit Aerial Couchtop (K200282) — FDA 510 (k) | Innolitics, Orfit-Industries FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200282 | Class II | Active |
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Manufacturer
- Manufacturer
- Orfit Industries NV
Sources (1)
- FDA 510(k) K200282 24 fields · synced Oct 6, 2026