Clearance Summary
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO received FDA 510(k) clearance under submission number K090991, sponsored by E-Woo Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-10-09.
- Submission: K090991
- Applicant / Sponsor: E-Woo Technology
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2009-10-09
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.