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)

DuoFLEX Coil Suite

K-Number: K173290 · 2017-11-28

ApplicantMr Instruments, Inc.
Decision Date2017-11-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DuoFLEX Coil Suite is a medical device manufactured by Mr Instruments, Inc.. It received FDA 510(k) clearance on 2017-11-28 under approval number K173290. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuoFLEX Coil Suite?

DuoFLEX Coil Suite is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by Mr Instruments, Inc.. The 510(k) number is K173290.

When was DuoFLEX Coil Suite approved by the FDA?

DuoFLEX Coil Suite received FDA 510(k) clearance on 2017-11-28, under approval number K173290.

What company makes DuoFLEX Coil Suite?

DuoFLEX Coil Suite is manufactured by Mr Instruments, Inc..

What is the FDA product code for DuoFLEX Coil Suite?

The FDA product code for DuoFLEX Coil Suite is MOS.

Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

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.

↑