Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit

K-Number: K153343 · 2016-04-15

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2016-04-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K153343. 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, MAGNETOM Prisma fit?

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K153343.

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

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit received FDA 510(k) clearance on 2016-04-15, under approval number K153343.

What company makes MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit?

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit is manufactured by Siemens Medi Cal Solutions, Inc..

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

The FDA product code for MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit is LNH.

Other Devices by Siemens Medi Cal Solutions, Inc.

K162102MAGNETOM Avantofit, MAGNETOM Skyrafit K162417Acuson Freestyle Ultrasound System K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System K153360ADMIRE K171766Acuson SC2000 Diagnostic Ultrasound System K170315Acuson SC2000 Diagnostic Ultrasound System

View all 14 devices →

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.

↑