Clearance Summary
Vivid T8, Vivid T9 received FDA 510(k) clearance under submission number K181934, sponsored by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-11-06.
- Submission: K181934
- Applicant / Sponsor: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2018-11-06
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.