The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Pixium 4343rce.
| Device ID | K170113 |
| 510k Number | K170113 |
| Device Name: | Pixium 4343RCE |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Contact | Ming Xiao |
| Correspondent | Ming Xiao Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2017-02-09 |
| Summary: | summary |