The following data is part of a premarket notification filed by Siemens Medical Solution Usa, Inc. with the FDA for Syngo Application Software.
| Device ID | K163285 |
| 510k Number | K163285 |
| Device Name: | Syngo Application Software |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTION USA, INC. 40 LIBERTY BOULEVARD 65-1A Malvern, PA 19355 |
| Contact | Patricia D. Jones |
| Correspondent | Patricia D. Jones SIEMENS MEDICAL SOLUTION 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 | 2016-11-22 |
| Decision Date | 2017-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869050874 | K163285 | 000 |