FDA 510(k)

BrightHeart View Classifier

K-Number: K251456 · 2025-06-05

Decision Date2025-06-05

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BrightHeart View Classifier is the device name listed in this FDA 510(k) record. The listed applicant is Brightheart. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K251456. 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 BrightHeart View Classifier?

BrightHeart View Classifier is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Brightheart. The 510(k) number is K251456.

When did BrightHeart View Classifier receive FDA 510(k) clearance?

BrightHeart View Classifier received FDA 510(k) clearance on 2025-06-05, under 510(k) number K251456.

Who is the listed applicant for BrightHeart View Classifier?

The FDA 510(k) record lists Brightheart as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BrightHeart View Classifier?

The FDA product code for BrightHeart View Classifier is QIH.

Other records listing Brightheart 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.

K252294Fetal EchoScan (v1.2)K243684BrightHeart View Classifier K251071Fetal EchoScan (v1.1)K242342Fetal EchoScan

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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.