510(k) K232058
K232058 is an FDA 510(k) premarket notification submitted by Careray Digital Medical Technology Co., Ltd. for the device "YosemiteView 4343W/YosemiteView 3643W". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Careray Digital Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2023
- Date Received
- July 11, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type