510(k) K230059
K230059 is an FDA 510(k) premarket notification submitted by Ray Imaging Technology (Haining) Limited for the device "Digital Flat Panel Detector". The FDA issued a decision of Substantially Equivalent on Feb 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2023
- Date Received
- Jan 9, 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
- 510(k)