FDA 510(k)

Rapid (6.0)

K-Number: K233512 · 2024-01-16

Decision Date2024-01-16

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rapid (6.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K233512. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid (6.0)?

Rapid (6.0) is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Ischemaview, Inc.. The 510(k) number is K233512.

When did Rapid (6.0) receive FDA 510(k) clearance?

Rapid (6.0) received FDA 510(k) clearance on 2024-01-16, under 510(k) number K233512.

Who is the listed applicant for Rapid (6.0)?

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 (6.0)?

The FDA product code for Rapid (6.0) is QIH.

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 Measurements K251533Rapid Obstructive Hydrocephalus, Rapid OH K252526Rapid DeltaFuse K251151Rapid CTA 360 K243378Rapid MLS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.