The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Ysio Max.
| Device ID | K181279 | 
| 510k Number | K181279 | 
| Device Name: | Ysio Max | 
| Classification | System, X-ray, Stationary | 
| Applicant | Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 | 
| Contact | Denise Adams | 
| Correspondent | Denise Adams Siemens Medical Solutions, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 | 
| Product Code | KPR | 
| CFR Regulation Number | 892.1680 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2018-05-15 | 
| Decision Date | 2018-06-13 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  YSIO MAX  79140428  4630395 Live/Registered | Siemens Healthcare GmbH 2013-11-07 |