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FDA 510(k)

Rapid CTA 360

K-Number: K251151 · 2025-07-16

ApplicantIschemaview
Decision Date2025-07-16
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid CTA 360 is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K251151. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid CTA 360?

Rapid CTA 360 is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Ischemaview. The 510(k) number is K251151.

When did Rapid CTA 360 receive FDA 510(k) clearance?

Rapid CTA 360 received FDA 510(k) clearance on 2025-07-16, under 510(k) number K251151.

Who is the listed applicant for Rapid CTA 360?

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

What is the FDA product code for Rapid CTA 360?

The FDA product code for Rapid CTA 360 is QAS.

Other records listing Ischemaview 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.

K261085Rapid Vessel Occlusion (Rapid VO)K251987Rapid Aortic MeasurementsK251533Rapid Obstructive Hydrocephalus, Rapid OHK252526Rapid DeltaFuseK243378Rapid MLSK243350Rapid Neuro3D

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Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, 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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