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FDA 510(k)

Rapid ASPECTS (v3)

K-Number: K232156 · 2024-01-19

ApplicantIschemaview, Inc.
Decision Date2024-01-19
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid ASPECTS (v3) is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K232156. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid ASPECTS (v3)?

Rapid ASPECTS (v3) is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Ischemaview, Inc.. The 510(k) number is K232156.

When did Rapid ASPECTS (v3) receive FDA 510(k) clearance?

Rapid ASPECTS (v3) received FDA 510(k) clearance on 2024-01-19, under 510(k) number K232156.

Who is the listed applicant for Rapid ASPECTS (v3)?

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 ASPECTS (v3)?

The FDA product code for Rapid ASPECTS (v3) is POK.

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: POK)

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.

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonioK254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294Fetal EchoScan (v1.2)BrightheartK250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.

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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