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FDA 510(k)

YSIO X.pree

K-Number: K250738 · 2025-07-31

ApplicantSiemens Medical Solutions
Decision Date2025-07-31
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

YSIO X.pree is a medical device manufactured by Siemens Medical Solutions. It received FDA 510(k) clearance on 2025-07-31 under approval number K250738. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YSIO X.pree?

YSIO X.pree is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Siemens Medical Solutions. The 510(k) number is K250738.

When was YSIO X.pree approved by the FDA?

YSIO X.pree received FDA 510(k) clearance on 2025-07-31, under approval number K250738.

What company makes YSIO X.pree?

YSIO X.pree is manufactured by Siemens Medical Solutions.

What is the FDA product code for YSIO X.pree?

The FDA product code for YSIO X.pree is KPR.

Other Devices by Siemens Medical Solutions

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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