Clearance Summary
SR-8100 Portable X-ray Unit received FDA 510(k) clearance under submission number K200637, sponsored by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-07-09.
- Submission: K200637
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2020-07-09
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.