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)

Vantage Galan 3T, MRT-3020, V4.0

K-Number: K162183 · 2016-11-25

ApplicantToshibamedical Systems Corporation
Decision Date2016-11-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020, V4.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-11-25 under approval number K162183. 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 Vantage Galan 3T, MRT-3020, V4.0?

Vantage Galan 3T, MRT-3020, V4.0 is a medical device that received FDA 510(k) clearance on 2016-11-25. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K162183.

When was Vantage Galan 3T, MRT-3020, V4.0 approved by the FDA?

Vantage Galan 3T, MRT-3020, V4.0 received FDA 510(k) clearance on 2016-11-25, under approval number K162183.

What company makes Vantage Galan 3T, MRT-3020, V4.0?

Vantage Galan 3T, MRT-3020, V4.0 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Vantage Galan 3T, MRT-3020, V4.0?

The FDA product code for Vantage Galan 3T, MRT-3020, V4.0 is LNH.

Other Devices by Toshibamedical Systems Corporation

K162155Xario 200 Diagnostic Ultrasound System V5.0 K162614Infinix, INFX-8000V, V6.35 K162187Xario 100 Diagnostic Ultrasound System, V5.0 K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 K160632Vantage Titan 1.5T, MRT-1510, V3.6 Software K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

View all 27 devices →

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. 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. K161567SIGNA VoyagerGE Healthcare

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.

↑