Clearance Summary
Dolphin/IQ, Dolphin/4D and Dolphin/MAX received FDA 510(k) clearance under submission number K191023, sponsored by Viasonix , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-05-16.
- Submission: K191023
- Applicant / Sponsor: Viasonix , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2019-05-16
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.