510(k) K131211
K131211 is an FDA 510(k) premarket notification submitted by Oehm Und Rehbein GmbH for the device "DICOMPACS DX-R WITH FLAT PANEL". The FDA issued a decision of Substantially Equivalent on Nov 5, 2013. 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. Oehm Und Rehbein GmbH has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2013
- Date Received
- Apr 29, 2013
- 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)