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FDA 510(k)

Ysio Max

K-Number: K181279 · 2018-06-13

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2018-06-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ysio Max is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K181279. 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 Max?

Ysio Max is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K181279.

When was Ysio Max approved by the FDA?

Ysio Max received FDA 510(k) clearance on 2018-06-13, under approval number K181279.

What company makes Ysio Max?

Ysio Max is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for Ysio Max?

The FDA product code for Ysio Max is KPR.

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Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K161937CuattroDRCuattro, LLC K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.

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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