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FDA 510(k)

MVision AI Segmentation

K-Number: K212915 · 2022-05-03

ApplicantMVision AI
Decision Date2022-05-03
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MVision AI Segmentation is a medical device manufactured by MVision AI. It received FDA 510(k) clearance on 2022-05-03 under approval number K212915. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MVision AI Segmentation?

MVision AI Segmentation is a medical device that received FDA 510(k) clearance on 2022-05-03. It is manufactured by MVision AI. The 510(k) number is K212915.

When was MVision AI Segmentation approved by the FDA?

MVision AI Segmentation received FDA 510(k) clearance on 2022-05-03, under approval number K212915.

What company makes MVision AI Segmentation?

MVision AI Segmentation is manufactured by MVision AI.

What is the FDA product code for MVision AI Segmentation?

The FDA product code for MVision AI Segmentation is QKB.

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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.

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