Clearance Summary
WBR XPRESS3.CARDIAC received FDA 510(k) clearance under submission number K081201, sponsored by Ultraspect , 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 2008-05-28.
- Submission: K081201
- Applicant / Sponsor: Ultraspect , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2008-05-28
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.