510(k) K221144
K221144 is an FDA 510(k) premarket notification submitted by Radisen Co., Ltd. for the device "PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG". The FDA issued a decision of Substantially Equivalent on May 13, 2022. 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. Radisen Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2022
- Date Received
- Apr 20, 2022
- 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)