YSIO X.pree
GUDID 04056869962214
Siemens Healthcare GmbH
Stationary basic diagnostic x-ray system, digital| Primary Device ID | 04056869962214 |
| NIH Device Record Key | 63f72c07-08b3-4d43-a600-055d0d307cfb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | YSIO X.pree |
| Version Model Number | 11574001 |
| Company DUNS | 313217003 |
| Company Name | Siemens Healthcare GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)888-7436 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869962214 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K250738
FDA Product Code
| KPR | System, x-ray, stationary |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-19 |
| Device Publish Date | 2025-08-11 |
On-Brand Devices [YSIO X.pree]
| 04056869232904 | 11107464 |
| 04056869962214 | 11574001 |
Trademark Results [YSIO X.pree]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 YSIO X.PREE 79283052 not registered Live/Pending |
Siemens Healthcare GmbH 2020-03-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.