The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Dynamics (version Va40e).
| Device ID | K220832 |
| 510k Number | K220832 |
| Device Name: | Syngo Dynamics (Version VA40E) |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 400 W. Morgan Road Ann Arbor, MI 48108 |
| Contact | Abhineet Johri |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869287362 | K220832 | 000 |