510(k) K220277
K220277 is an FDA 510(k) premarket notification submitted by Shenzhen Xpectvision Technology Co., Ltd. for the device "Digital Intraoral X-ray Sensor". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Shenzhen Xpectvision Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2022
- Date Received
- January 31, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type