Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories
510(k) K060671
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060671 | Date4 May 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Questions
AI-generated answers, 24 Sep 2026
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.