The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Syngo.mr Applications.
| Device ID | K192462 |
| 510k Number | K192462 |
| Device Name: | Syngo.MR Applications |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, MailCode 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, MailCode 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 | 2019-09-09 |
| Decision Date | 2020-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869230214 | K192462 | 000 |
| 04056869296210 | K192462 | 000 |
| 04056869953014 | K192462 | 000 |