Clearance Summary
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE received FDA 510(k) clearance under submission number K141900, 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 2015-05-20.
- Submission: K141900
- Applicant / Sponsor: Eckert & Ziegler Bebig GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2015-05-20
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.