Qfix Radiotherapy Chair

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

510(k) Number

K120916 ↗

FDA Product Code

JAI

Device Class

Class II

Regulation

21 CFR Part 892.5770

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Wfr/Aquaplast Corp. →

• What is the Qfix Radiotherapy Chair used for?

  The Qfix Radiotherapy Chair is a Class II medical device designed for patient positioning and immobilization during radiation therapy procedures. It is a powered couch that helps stabilize patients during treatment.

• Is the Qfix Radiotherapy Chair single-use or reusable?

  The Qfix Radiotherapy Chair can be either single-use or reusable depending on the clinical protocol. This determination is made by the healthcare facility based on their specific treatment protocols and infection control requirements.

• What accessories are compatible with the Qfix Radiotherapy Chair?

  The Qfix Radiotherapy Chair can accommodate the Qfix Accubite™ bite block stabilization system along with various WFR/Aquaplast masks for fixation, providing multiple options for patient immobilization during radiation therapy.

• What is the regulatory status of the Qfix Radiotherapy Chair?

  The Qfix Radiotherapy Chair received FDA 510(k) clearance with K-number K120916 in 2012 and is regulated under product code JAI for radiology applications. It is MRI conditional and requires appropriate storage conditions.