510(k) K210312
K210312 is an FDA 510(k) premarket notification submitted by Iray Technology Taicang , Ltd. for the device "PlutoX Digital Intraoral X-Ray Imaging System". The FDA issued a decision of Substantially Equivalent on Apr 23, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Iray Technology Taicang , Ltd. has 20 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2021
- Date Received
- Feb 3, 2021
- 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
- 510(k)