Clearance Summary
PROBEAT-CR received FDA 510(k) clearance under submission number K191801, sponsored by Hitachi , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-09-13.
- Submission: K191801
- Applicant / Sponsor: Hitachi , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2019-09-13
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.