The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Philips Prograde; Philips Eleva Workspot For Digital Diagnost.
| Device ID | K141736 |
| 510k Number | K141736 |
| Device Name: | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST |
| 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 | 2014-06-27 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086753 | K141736 | 000 |
| 00884838065222 | K141736 | 000 |
| 00884838065239 | K141736 | 000 |
| 00884838065321 | K141736 | 000 |
| 00884838074514 | K141736 | 000 |
| 00884838074521 | K141736 | 000 |
| 00884838074538 | K141736 | 000 |
| 00884838074705 | K141736 | 000 |
| 00884838084636 | K141736 | 000 |
| 00884838085671 | K141736 | 000 |
| 00884838085688 | K141736 | 000 |
| 00884838085695 | K141736 | 000 |
| 00884838065215 | K141736 | 000 |