Clearance Summary
Mini Ridge Filter and auxiliary functions for PROBEAT-V received FDA 510(k) clearance under submission number K181676, sponsored by Hitachi Ltd. Healthcare Hitachi Works. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-08-15.
- Submission: K181676
- Applicant / Sponsor: Hitachi Ltd. Healthcare Hitachi Works
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2018-08-15
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.