The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Syngo Ultrasound Apps Suite (susas).
| Device ID | K201062 |
| 510k Number | K201062 |
| Device Name: | Syngo Ultrasound Apps Suite (sUSAS) |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions, USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar Siemens Medical Solutions, USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-05-18 |