YSIO X.pree
FDA 510(k) K233543 · Siemens Medical Solutions
510(k) numberK233543
Submission
- Device name
- YSIO X.pree
- Applicant
- Siemens Medical Solutions
Malvern, PA, US - Received
- November 3, 2023
- Decision date
- May 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250738 | YSIO X.preeKPR · Traditional | 07/31/2025SE |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix ROWB · Traditional | 07/14/2025SE |
| K233532 | MULTIX Impact EKPR · Special | 11/29/2023SE |
| K231577 | MOBILETT ImpactIZL · Traditional | 07/25/2023SE |
| K221281 | Multitom RaxOWB · Traditional | 11/17/2022SE |
| K212212 | Multitom Rax with True2scale Body Scan OptionOWB · Traditional | 02/18/2022SE |
| K101749 | Syngo Trued SoftwareLLZ · Traditional | 08/16/2010SE |
| K081018 | Syngo Dynamics Version 7.0LLZ · Special | 04/25/2008SE |
| K071513 | Inspace 4D Software Package with Extended FunctionalityJAK · Traditional | 06/26/2007SE |
| K070629 | Flex and Loop Coil Set 1.5 TMOS · Traditional | 03/26/2007SE |
Questions and answers
When was YSIO X.pree cleared by the FDA?
YSIO X.pree (K233543) received a 510(k) decision of Substantially Equivalent on May 21, 2024, 200 days after the submission was received.
What is the product code of K233543?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.