FDA 510(k)

SIGNA 7.0T

K-Number: K211118 · 2021-05-13

Decision Date2021-05-13

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIGNA 7.0T is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-05-13 under approval number K211118. 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 SIGNA 7.0T?

SIGNA 7.0T is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K211118.

When was SIGNA 7.0T approved by the FDA?

SIGNA 7.0T received FDA 510(k) clearance on 2021-05-13, under approval number K211118.

What company makes SIGNA 7.0T?

SIGNA 7.0T is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for SIGNA 7.0T?

The FDA product code for SIGNA 7.0T is LNH.

Other Devices by Ge Medical Systems, LLC

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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.