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 Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

K-Number: K211633 · 2021-07-22

ApplicantCanon Medical Systems Corporation
Decision Date2021-07-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-07-22 under approval number K211633. 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 Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K211633.

When was Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR approved by the FDA?

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR received FDA 510(k) clearance on 2021-07-22, under approval number K211633.

What company makes Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR?

The FDA product code for Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR is LNH.

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

Other Devices by Canon Medical Systems Corporation

K182601Vitrea Software Package, VSTP-001A K183013Vitrea Software Package, VSTP-001A K181646Celesteion, PCA-9000A/3, V6.5 K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

View all 96 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.

↑