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FDA 510(k)

DrAid™ for Liver Segmentation

K-Number: K241543 · 2024-12-06

Decision Date2024-12-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DrAid™ for Liver Segmentation is the device name listed in this FDA 510(k) record. The listed applicant is Vinbrain Joint Stock Company. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241543. 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 DrAid™ for Liver Segmentation?

DrAid™ for Liver Segmentation is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Vinbrain Joint Stock Company. The 510(k) number is K241543.

When did DrAid™ for Liver Segmentation receive FDA 510(k) clearance?

DrAid™ for Liver Segmentation received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241543.

Who is the listed applicant for DrAid™ for Liver Segmentation?

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

What is the FDA product code for DrAid™ for Liver Segmentation?

The FDA product code for DrAid™ for Liver Segmentation is QIH.

Other records listing Vinbrain Joint Stock Company 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.

Related Devices (Code: QIH)

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.

Official Source

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