Clearance Summary
YosemiteView 4343W/YosemiteView 3643W received FDA 510(k) clearance under submission number K232058, sponsored by Careray Digital Medical Technology 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 2023-08-03.
- Submission: K232058
- Applicant / Sponsor: Careray Digital Medical Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2023-08-03
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.