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FDA 510(k)

YSIO X.pree

K-Number: K201670 · 2020-10-21

Decision Date2020-10-21
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

YSIO X.pree is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201670. 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 2020-10-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K201670.

When did YSIO X.pree receive FDA 510(k) clearance?

YSIO X.pree received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201670.

Who is the listed applicant for YSIO X.pree?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Siemens Medical Solutions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 252 devices →

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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