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 | K190780 |
| 510k Number | K190780 |
| 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 | 2019-03-27 |
| Decision Date | 2019-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869124162 | K190780 | 000 |
| 04056869248653 | K190780 | 000 |