The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo.plaza.
| Device ID | K093612 | 
| 510k Number | K093612 | 
| Device Name: | SYNGO.PLAZA | 
| Classification | System, Image Processing, Radiological | 
| Applicant | 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 | Yes | 
| Combination Product | No | 
| Date Received | 2009-11-23 | 
| Decision Date | 2010-03-04 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYNGO.PLAZA  79073973  3785042 Live/Registered | Siemens Healthcare GmbH 2009-06-30 |