Cleared Traditional

QFIX RADIOTHERAPY CHAIR

K120916 · Wfr/Aquaplast Corp. · Radiology
Jun 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K120916 is an FDA 510(k) clearance for the QFIX RADIOTHERAPY CHAIR, a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI), submitted by Wfr/Aquaplast Corp. (Avondale, US). The FDA issued a Cleared decision on June 20, 2012, 85 days after receiving the submission on March 27, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5770.

Submission Details

510(k) Number K120916 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2012
Decision Date June 20, 2012
Days to Decision 85 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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