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FDA 510(k)

MAGNETOM Sola

K-Number: K181322 · 2018-10-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-10-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Sola is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2018-10-05 under approval number K181322. 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 Sola?

MAGNETOM Sola is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K181322.

When was MAGNETOM Sola approved by the FDA?

MAGNETOM Sola received FDA 510(k) clearance on 2018-10-05, under approval number K181322.

What company makes MAGNETOM Sola?

MAGNETOM Sola is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for MAGNETOM Sola?

The FDA product code for MAGNETOM Sola is LNH.

Other Devices by Siemens Medical Solutions USA, Inc.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

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Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

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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