Clearance Summary
EVS 3643, EVS 3643G received FDA 510(k) clearance under submission number K162552, sponsored by DRTECH Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-12-02.
- Submission: K162552
- Applicant / Sponsor: DRTECH Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2016-12-02
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.