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FDA 510(k)

Rapid PE Triage and Notification (PETN)

K-Number: K220499 · 2022-05-17

ApplicantIschemaview, Inc.
Decision Date2022-05-17
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid PE Triage and Notification (PETN) is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K220499. 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 PE Triage and Notification (PETN)?

Rapid PE Triage and Notification (PETN) is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Ischemaview, Inc.. The 510(k) number is K220499.

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

Rapid PE Triage and Notification (PETN) received FDA 510(k) clearance on 2022-05-17, under 510(k) number K220499.

Who is the listed applicant for Rapid PE Triage and Notification (PETN)?

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 PE Triage and Notification (PETN)?

The FDA product code for Rapid PE Triage and Notification (PETN) is QAS.

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.

K261085Rapid Vessel Occlusion (Rapid VO)K251987Rapid Aortic MeasurementsK251533Rapid Obstructive Hydrocephalus, Rapid OHK252526Rapid DeltaFuseK251151Rapid CTA 360K243378Rapid MLS

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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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