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FDA 510(k)

INNOVISION-DXII

K-Number: K250790 · 2025-08-01

ApplicantDk Medical Systems Co., Ltd.
Decision Date2025-08-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVISION-DXII is a medical device manufactured by Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-08-01 under approval number K250790. 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 INNOVISION-DXII?

INNOVISION-DXII is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Dk Medical Systems Co., Ltd.. The 510(k) number is K250790.

When was INNOVISION-DXII approved by the FDA?

INNOVISION-DXII received FDA 510(k) clearance on 2025-08-01, under approval number K250790.

What company makes INNOVISION-DXII?

INNOVISION-DXII is manufactured by Dk Medical Systems Co., Ltd..

What is the FDA product code for INNOVISION-DXII?

The FDA product code for INNOVISION-DXII is KPR.

Other Devices by Dk Medical Systems Co., Ltd.

K250750INNOVISION-P5 K253446AeroDR TX c02

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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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