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FDA 510(k)

SureWave Elastography (Q7000225)

K-Number: K242006 · 2025-02-12

ApplicantQuality Electrodynamics, LLC
Decision Date2025-02-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SureWave Elastography (Q7000225) is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2025-02-12 under approval number K242006. 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 SureWave Elastography (Q7000225)?

SureWave Elastography (Q7000225) is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K242006.

When was SureWave Elastography (Q7000225) approved by the FDA?

SureWave Elastography (Q7000225) received FDA 510(k) clearance on 2025-02-12, under approval number K242006.

What company makes SureWave Elastography (Q7000225)?

SureWave Elastography (Q7000225) is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for SureWave Elastography (Q7000225)?

The FDA product code for SureWave Elastography (Q7000225) is LNH.

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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.

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