BrightHeart View Classifier
K-Number: K243684 · 2025-05-07
ApplicantBrightheart
Decision Date2025-05-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BrightHeart View Classifier is a medical device manufactured by Brightheart. It received FDA 510(k) clearance on 2025-05-07 under approval number K243684. 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 2025-05-07. It is manufactured by Brightheart. The 510(k) number is K243684.
When was BrightHeart View Classifier approved by the FDA?
BrightHeart View Classifier received FDA 510(k) clearance on 2025-05-07, under approval number K243684.
What company makes BrightHeart View Classifier?
BrightHeart View Classifier is manufactured by Brightheart.
What is the FDA product code for BrightHeart View Classifier?
The FDA product code for BrightHeart View Classifier is QIH.
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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.