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Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories

by Wfr/Aquaplast Corp.

510(k) K060671

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060671 Date4 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Kvue Igrt Treatment Table Top, Rt-4551KV, Kvue Inserts and Accessories, Various
510(k) Number
FDA Product Code
JAI
Device Class
Class II
Regulation
21 CFR Part 892.5770
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kvue IGRT Treatment Table Top, inserts, and accessories are radiation therapy couch components designed to position and support patients during treatment. This device is intended to replace an original equipment manufacturer's stock table top to facilitate radiation therapy procedures.

Constructed with sliding beams and fiber composites, the system contains no metal parts in the treatment area. This device has received FDA 510k clearance and is classified under regulation number 892.5770.

Other devices from Wfr/Aquaplast Corp.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Kvue IGRT Treatment Table Top?

    The Kvue IGRT Treatment Table Top, along with its associated inserts and accessories, is designed to position and support patients during radiation therapy procedures. It is intended to replace an original equipment manufacturer's stock table top to facilitate these treatments.

  • What materials are used in the construction of this system?

    The system is constructed using sliding beams and fiber composites. A key feature of this design is that it contains no metal parts within the treatment area, which helps ensure the integrity of the radiation therapy environment.

  • What is the regulatory status of the Kvue IGRT system?

    The Kvue IGRT Treatment Table Top, RT-4551KV, and its accessories have received FDA 510k clearance. The device is classified under regulation number 892.5770, which pertains to powered radiation therapy couches.