Siemens Medical Solutions
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K250738 | YSIO X.pree | July 31, 2025 |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | July 14, 2025 |
| K233543 | YSIO X.pree | May 21, 2024 |
| K233532 | MULTIX Impact E | November 29, 2023 |
| K231577 | MOBILETT Impact | July 25, 2023 |
| K221281 | Multitom Rax | November 17, 2022 |
| K212212 | Multitom Rax with True2scale Body Scan Option | February 18, 2022 |
| K101749 | SYNGO TRUED SOFTWARE | August 16, 2010 |
| K081018 | SYNGO DYNAMICS VERSION 7.0 | April 25, 2008 |
| K071513 | INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | June 26, 2007 |
| K070629 | FLEX AND LOOP COIL SET 1.5 T | March 26, 2007 |
| K061671 | SYNGO TRUED, MODEL VC10A | June 29, 2006 |
| K060992 | SYNGO US WORKPLACE | April 28, 2006 |
| K043030 | MAGNETOM C! MR SYSTEM | December 9, 2004 |
| K030657 | SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 | March 21, 2003 |