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Table Tilt Device (K033316)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033316

by Brainlab AG

Identifiers

510(k) Number
K033316 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 Table Tilt Device is a powered radiation therapy couch accessory classified as a Radiation Therapy, Powered Couch under FDA nomenclature. It provides motorized adjustments to tilt the treatment table around both the lateral and longitudinal axes, enabling precise compensation for patient misalignment or rotational shifts during radiation therapy sessions.

This device is intended for use in radiation oncology settings and is supplied as a standalone attachment to existing treatment tables. It is a reusable, non-sterile Class II medical device, with FDA 510(k) clearance (K033316) under the Radiation Therapy, Powered Couch product code (JAI). No MRI safety or sterility requirements are specified in the regulatory submission.

Frequently asked questions

How is the Table Tilt Device installed and does it work with existing treatment tables?

The Table Tilt Device is designed as a standalone attachment meant to be integrated with existing radiation therapy treatment tables. It provides motorized adjustments for tilting the table along both the lateral and longitudinal axes, allowing precise alignment corrections during therapy sessions without requiring modifications to the base table structure.

Is the Table Tilt Device reusable or single-use, and what are its sterility requirements?

The Table Tilt Device is a reusable, non-sterile Class II medical device. Since it is not intended for direct patient contact during therapy (as it attaches to the treatment table), no sterility requirements are specified in its regulatory submission, and it is not required to be sterile.

What types of radiation therapy settings is this device intended for, and how does it address patient positioning challenges?

This device is specifically intended for use in radiation oncology settings where precise patient alignment is critical. It compensates for patient misalignment or rotational shifts by enabling motorized adjustments to tilt the treatment table around both the lateral (side-to-side) and longitudinal (head-to-foot) axes, ensuring accurate targeting during therapy sessions.

What regulatory pathway was followed for clearance, and which advisory committee was involved?

The Table Tilt Device received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent (SESE) under the Radiation Therapy, Powered Couch product code (JAI). The Radiology (RA) advisory committee was involved in the review process, as indicated in the regulatory submission.

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 510 (k) Summary of Safety and Effectiveness MAY 1 4 2004 for Table Tilt ..., Table Tilt Device 510 (k) FDA Premarket Notification K033316 BRAINLAB AG, TABLE TILT DEVICE (K033316) — FDA 510 (k) | Innolitics, Brainlab Table Tilt - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K033316 24 fields · synced Sep 19, 2026