Clearance Summary
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory received FDA 510(k) clearance under submission number K202742, sponsored by Viasonix , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-01-25.
- Submission: K202742
- Applicant / Sponsor: Viasonix , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2021-01-25
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.