510(k) K211108
K211108 is an FDA 510(k) premarket notification submitted by Pixxgen Corporation for the device "Prudent 1717, Prudent 1417, Prudent 1212". The FDA issued a decision of Substantially Equivalent on Jun 4, 2021. 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. Pixxgen Corporation has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 4, 2021
- Date Received
- Apr 14, 2021
- Clearance Type
- Traditional
- 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)