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FDA 510(k)

Rapid Neuro3D

K-Number: K243350 · 2025-01-22

ApplicantIschemaview, Inc.
Decision Date2025-01-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid Neuro3D is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-01-22 under approval number K243350. 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 Rapid Neuro3D?

Rapid Neuro3D is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Ischemaview, Inc.. The 510(k) number is K243350.

When was Rapid Neuro3D approved by the FDA?

Rapid Neuro3D received FDA 510(k) clearance on 2025-01-22, under approval number K243350.

What company makes Rapid Neuro3D?

Rapid Neuro3D is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid Neuro3D?

The FDA product code for Rapid Neuro3D is QIH.

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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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