Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is MVision AI. It received FDA 510(k) clearance on 2022-05-03 under 510(k) 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. The listed applicant is MVision AI. The 510(k) number is K212915.

When did MVision AI Segmentation receive FDA 510(k) clearance?

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

Who is the listed applicant for MVision AI Segmentation?

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

What is the FDA product code for MVision AI Segmentation?

The FDA product code for MVision AI Segmentation is QKB.

Related Devices (Code: QKB)

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.

K262452AutoContour (RADAC V6)Radformation, Inc.K261306AI Contouring (VA10A)Varian Medical SystemsK260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.

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.

↑