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

FDA 510(k)

QSM software, QSMetric

K-Number: K210415 · 2021-07-22

Decision Date2021-07-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QSM software, QSMetric is a medical device manufactured by Medimagemetric, LLC. It received FDA 510(k) clearance on 2021-07-22 under approval number K210415. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QSM software, QSMetric?

QSM software, QSMetric is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Medimagemetric, LLC. The 510(k) number is K210415.

When was QSM software, QSMetric approved by the FDA?

QSM software, QSMetric received FDA 510(k) clearance on 2021-07-22, under approval number K210415.

What company makes QSM software, QSMetric?

QSM software, QSMetric is manufactured by Medimagemetric, LLC.

What is the FDA product code for QSM software, QSMetric?

The FDA product code for QSM software, QSMetric is LNH.

Related Devices (Code: LNH)

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.