FDA 510(k)

Rapid MLS

K-Number: K243378 · 2025-05-28

Decision Date2025-05-28

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rapid MLS is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K243378. 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 MLS?

Rapid MLS is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Ischemaview, Inc.. The 510(k) number is K243378.

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

Rapid MLS received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243378.

Who is the listed applicant for Rapid MLS?

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 MLS?

The FDA product code for Rapid MLS 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.