Clearance Summary
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) received FDA 510(k) clearance under submission number K201932, sponsored by Careray Digital Medical System Co., 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 2020-08-07.
- Submission: K201932
- Applicant / Sponsor: Careray Digital Medical System Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2020-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.