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)

MRIaudio PREM System with MRIview

K-Number: K193102 · 2020-01-06

ApplicantMriaudio, Inc.
Decision Date2020-01-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRIaudio PREM System with MRIview is a medical device manufactured by Mriaudio, Inc.. It received FDA 510(k) clearance on 2020-01-06 under approval number K193102. 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 MRIaudio PREM System with MRIview?

MRIaudio PREM System with MRIview is a medical device that received FDA 510(k) clearance on 2020-01-06. It is manufactured by Mriaudio, Inc.. The 510(k) number is K193102.

When was MRIaudio PREM System with MRIview approved by the FDA?

MRIaudio PREM System with MRIview received FDA 510(k) clearance on 2020-01-06, under approval number K193102.

What company makes MRIaudio PREM System with MRIview?

MRIaudio PREM System with MRIview is manufactured by Mriaudio, Inc..

What is the FDA product code for MRIaudio PREM System with MRIview?

The FDA product code for MRIaudio PREM System with MRIview is LNH.

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.

↑