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FDA 510(k)

MAGNETOM Cima.X

K-Number: K231587 · 2023-12-18

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-12-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Cima.X is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-12-18 under 510(k) number K231587. 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 MAGNETOM Cima.X?

MAGNETOM Cima.X is a medical device that received FDA 510(k) clearance on 2023-12-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K231587.

When did MAGNETOM Cima.X receive FDA 510(k) clearance?

MAGNETOM Cima.X received FDA 510(k) clearance on 2023-12-18, under 510(k) number K231587.

Who is the listed applicant for MAGNETOM Cima.X?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNETOM Cima.X?

The FDA product code for MAGNETOM Cima.X 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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