Clearance Summary
Vivid S60N / Vivid S70N received FDA 510(k) clearance under submission number K211216, sponsored by GE Medical Systems Ultrasound and Primary Care Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-06-09.
- Submission: K211216
- Applicant / Sponsor: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2021-06-09
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.