Clearance Summary
uDR 592h, uDR 596i received FDA 510(k) clearance under submission number K181413, sponsored by Shanghai United Imaging Healthcare 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 2018-06-27.
- Submission: K181413
- Applicant / Sponsor: Shanghai United Imaging Healthcare Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2018-06-27
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.