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FDA 510(k)

Rapid Aneurysm Triage and Notification

K-Number: K230074 · 2023-07-27

ApplicantIschemaview, Inc.
Decision Date2023-07-27
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid Aneurysm Triage and Notification is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-07-27 under approval number K230074. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Aneurysm Triage and Notification?

Rapid Aneurysm Triage and Notification is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Ischemaview, Inc.. The 510(k) number is K230074.

When was Rapid Aneurysm Triage and Notification approved by the FDA?

Rapid Aneurysm Triage and Notification received FDA 510(k) clearance on 2023-07-27, under approval number K230074.

What company makes Rapid Aneurysm Triage and Notification?

Rapid Aneurysm Triage and Notification is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid Aneurysm Triage and Notification?

The FDA product code for Rapid Aneurysm Triage and Notification is QFM.

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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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