RoboCouch Patient Support System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042146 FDA 510(k)
- FDA Product Code
- JAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5770 FDA 510(k)
- Regulation Number
- 892.5770 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RoboCouch Patient Support System is a powered couch for radiation therapy, designed for the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. It is an electric, computer-controlled treatment table featuring a robotic arm that provides 6 degrees of freedom for precise patient orientation.
The device is supplied as a reusable system and is indicated for use in clinical settings requiring accurate patient positioning, such as radiosurgery and radiotherapy. It received FDA 510(k) clearance (K042146) on September 17, 2004, and is classified as a Class II device under regulation 892.5770 with product code JAI, intended for use in radiology.
Frequently asked questions
What is the RoboCouch Patient Support System used for?
The RoboCouch Patient Support System is designed for the support and positioning of a patient during radiosurgery and radiotherapy procedures, as well as other medical procedures requiring precise patient orientation, due to its robotic arm enabling 6 degrees of freedom for accurate alignment.
Is the RoboCouch Patient Support System reusable or single-use?
The device is supplied as a reusable system, meaning it is intended for multiple uses in clinical settings after appropriate cleaning and maintenance, as indicated in its description and regulatory documentation.
What type of clearance does the RoboCouch Patient Support System have?
The RoboCouch Patient Support System received FDA 510(k) clearance (K042146) on September 17, 2004, and is classified as a Class II device under regulation 892.5770 with product code JAI, based on a traditional submission found substantially equivalent to a 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: PDF SEP 17 2004 Traditional 510(k) Notification Accuray Incorporated ..., ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146) — FDA 510 (k) | Innolitics, ROBOCOUCH PATIENT SUPPORT SYSTEM 510 (k) K042146 - 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 | K042146 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (1)
- FDA 510(k) K042146 24 fields · synced Sep 24, 2026