The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc with the FDA for Syngo X-workplace Sw Vd10.
| Device ID | K143319 |
| 510k Number | K143319 |
| Device Name: | Syngo X-workplace SW VD10 |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions, Inc 51 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Patricia D. Jones |
| Correspondent | Patricia D. Jones Siemens Medical Solutions, Inc 51 Valley Stream Parkway Malvern, PA 19355 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-19 |
| Decision Date | 2015-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026305 | K143319 | 000 |
| 04056869020518 | K143319 | 000 |
| 04056869010113 | K143319 | 000 |