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 |