510(k) K180989
K180989 is an FDA 510(k) premarket notification submitted by Radisen, Inc. for the device "PEDRA-17F Digital Flat Panel X-ray Detector". The FDA issued a decision of Substantially Equivalent on Jun 13, 2018. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2018
- Date Received
- Apr 16, 2018
- 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)