The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Pixium 4343rc.
| Device ID | K131483 |
| 510k Number | K131483 |
| Device Name: | PHILIPS PIXIUM 4343RC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PHILIPS MEDICAL SYSTEMS DMC GMBH 409 WOODRIDGE DR. Seneca, SC 29672 |
| Contact | Jennifer Cartledge |
| Correspondent | Jennifer Cartledge PHILIPS MEDICAL SYSTEMS DMC GMBH 409 WOODRIDGE DR. Seneca, SC 29672 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2013-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074279 | K131483 | 000 |