The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.via View&go.
| Device ID | K221501 |
| 510k Number | K221501 |
| Device Name: | Syngo.via View&GO |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Healthcare GmBH Siemensstraße 1, Forchheim Erlangen, DE |
| Contact | Frederike Jakob |
| Correspondent | Frederike Jakob Siemens Healthcare GmBH Siemensstraße 1, Forchheim Erlangen, DE |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-23 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869288475 | K221501 | 000 |