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FDA 510(k)

iQ-solutions

K-Number: K231929 · 2023-12-18

ApplicantSydney Neuroimaging Analysis Centre Pty, Ltd.
Decision Date2023-12-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iQ-solutions is the device name listed in this FDA 510(k) record. The listed applicant is Sydney Neuroimaging Analysis Centre Pty, Ltd.. It received FDA 510(k) clearance on 2023-12-18 under 510(k) number K231929. 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 iQ-solutions?

iQ-solutions is a medical device that received FDA 510(k) clearance on 2023-12-18. The listed applicant is Sydney Neuroimaging Analysis Centre Pty, Ltd.. The 510(k) number is K231929.

When did iQ-solutions receive FDA 510(k) clearance?

iQ-solutions received FDA 510(k) clearance on 2023-12-18, under 510(k) number K231929.

Who is the listed applicant for iQ-solutions?

The FDA 510(k) record lists Sydney Neuroimaging Analysis Centre Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iQ-solutions?

The FDA product code for iQ-solutions is QIH.

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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.

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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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