Clearance Summary
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 received FDA 510(k) clearance under submission number K063029, sponsored by E-Z-Em, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-11-02.
- Submission: K063029
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2006-11-02
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.