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FDA 510(k)

PVAD IQ Software

K-Number: K252235 · 2025-12-18

Decision Date2025-12-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PVAD IQ Software is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasight , Ltd.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) 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. The listed applicant is Ultrasight , Ltd.. The 510(k) number is K252235.

When did PVAD IQ Software receive FDA 510(k) clearance?

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

Who is the listed applicant for PVAD IQ Software?

The FDA 510(k) record lists Ultrasight , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PVAD IQ Software?

The FDA product code for PVAD IQ Software is QIH.

Other records listing Ultrasight , Ltd. 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.

Related Devices (Code: QIH)

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.