The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo.via Web Viewer.
| Device ID | K130998 |
| 510k Number | K130998 |
| Device Name: | SYNGO.VIA WEB VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
| Contact | Sabine Schroedel |
| Correspondent | Sabine Schroedel SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2014-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869053592 | K130998 | 000 |
| 04056869047911 | K130998 | 000 |
| 04056869023977 | K130998 | 000 |
| 04056869008950 | K130998 | 000 |
| 04056869004754 | K130998 | 000 |