510(k) K193225
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography by
Konica Minolta Healthcare Americas, Inc.
— Product Code KPR
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2020
- Date Received
- November 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type