The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Application Software Vd11.
| Device ID | K153346 |
| 510k Number | K153346 |
| Device Name: | Syngo Application Software VD11 |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A 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 | 2015-11-20 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869025919 | K153346 | 000 |
| 04056869025902 | K153346 | 000 |
| 04056869012902 | K153346 | 000 |