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FDA 510(k)

PVAD IQ Software

K-Number: K252235 · 2025-12-18

ApplicantUltrasight , Ltd.
Decision Date2025-12-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PVAD IQ Software is a medical device manufactured by Ultrasight , Ltd.. It received FDA 510(k) clearance on 2025-12-18 under approval number K252235. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVAD IQ Software?

PVAD IQ Software is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Ultrasight , Ltd.. The 510(k) number is K252235.

When was PVAD IQ Software approved by the FDA?

PVAD IQ Software received FDA 510(k) clearance on 2025-12-18, under approval number K252235.

What company makes PVAD IQ Software?

PVAD IQ Software is manufactured by Ultrasight , Ltd..

What is the FDA product code for PVAD IQ Software?

The FDA product code for PVAD IQ Software is QIH.

Other Devices by Ultrasight , Ltd.

K251416UltraSight Guidance

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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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