Clearance Summary
ViewPoint 6 received FDA 510(k) clearance under submission number K203677, sponsored by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-01-15.
- Submission: K203677
- Applicant / Sponsor: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-01-15
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.