Clearance Summary
Ultimax-i, DREX-UI80 V1.60 received FDA 510(k) clearance under submission number K170832, sponsored by Toshibamedical Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-07-21.
- Submission: K170832
- Applicant / Sponsor: Toshibamedical Systems Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2017-07-21
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.