Cleared Traditional

KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS

K060671 · Wfr/Aquaplast Corp. · Radiology
May 2006
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K060671 is an FDA 510(k) clearance for the KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS, a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI), submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on May 4, 2006, 51 days after receiving the submission on March 14, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5770.

Submission Details

510(k) Number K060671 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2006
Decision Date May 04, 2006
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAI — Couch, Radiation Therapy, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5770

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