Clearance Summary
Paragon XHD Diagnostic Ultrasound System received FDA 510(k) clearance under submission number K191347, sponsored by Shenzhen Wisonic Medical Technology Co. , 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 2020-02-07.
- Submission: K191347
- Applicant / Sponsor: Shenzhen Wisonic Medical Technology Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2020-02-07
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.