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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 the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-07-27 under 510(k) 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. The listed applicant is Ischemaview, Inc.. The 510(k) number is K230074.

When did Rapid Aneurysm Triage and Notification receive FDA 510(k) clearance?

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

Who is the listed applicant for Rapid Aneurysm Triage and Notification?

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

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

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

Other records listing Ischemaview, Inc. 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.

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Related Devices (Code: QFM)

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

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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