Clearance Summary
SagiNova received FDA 510(k) clearance under submission number K142986, sponsored by Eckert & Ziegler Bebig GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-04-17.
- Submission: K142986
- Applicant / Sponsor: Eckert & Ziegler Bebig GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2015-04-17
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.