The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Eleva Workspot.
| Device ID | K140771 |
| 510k Number | K140771 |
| Device Name: | PHILIPS ELEVA WORKSPOT |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PHILIPS MEDICAL SYSTEMS DMC GMBH ROENTGENSTRASSE 24-26 Hamburg, DE 22335 |
| Contact | Gerold Schwarz |
| Correspondent | Gerold Schwarz 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 | 2014-03-27 |
| Decision Date | 2014-04-25 |
| Summary: | summary |