Clearance Summary
QFIX RADIOTHERAPY CHAIR received FDA 510(k) clearance under submission number K120916, sponsored by Wfr/Aquaplast Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-06-20.
- Submission: K120916
- Applicant / Sponsor: Wfr/Aquaplast Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5770
- Decision date: 2012-06-20
Classification & Regulation
This clearance is catalogued under FDA product code JAI and 21 CFR 892.5770, within the Radiology review panel as a Class II device.