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FDA 510(k)

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

K-Number: K202014 · 2020-09-08

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-09-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-09-08 under approval number K202014. 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 Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit?

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit is a medical device that received FDA 510(k) clearance on 2020-09-08. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K202014.

When was Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit approved by the FDA?

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit received FDA 510(k) clearance on 2020-09-08, under approval number K202014.

What company makes Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit?

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit?

The FDA product code for Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit 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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