Clearance Summary
PAX-DUO3D PLUS, PCT-5000 received FDA 510(k) clearance under submission number K121236, sponsored by VATECH Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-05-24.
- Submission: K121236
- Applicant / Sponsor: VATECH Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2012-05-24
Classification & Regulation
This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.