510(k) K260820
K260820 is an FDA 510(k) premarket notification submitted by Vieworks Co., Ltd. for the device "VIVIX-S 4386W (FXRD-4386WA)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. 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. Vieworks Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2026
- Date Received
- March 13, 2026
- 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