FDA 510(k)

Rapid RV/LV

K-Number: K223396 · 2023-02-01

Decision Date2023-02-01

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rapid RV/LV is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K223396. 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 RV/LV?

Rapid RV/LV is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Ischemaview, Inc.. The 510(k) number is K223396.

When did Rapid RV/LV receive FDA 510(k) clearance?

Rapid RV/LV received FDA 510(k) clearance on 2023-02-01, under 510(k) number K223396.

Who is the listed applicant for Rapid RV/LV?

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 RV/LV?

The FDA product code for Rapid RV/LV 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.

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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.