510(k) K170113
K170113 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "pixium 4343RCE". The FDA issued a decision of Substantially Equivalent on Feb 9, 2017. 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. Philips Medical Systems Dmc GmbH has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 2017
- Date Received
- Jan 12, 2017
- 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)