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

FDA 510(k)

DUOFLEX COIL SUITE (1.5T)

K-Number: K130706 · 2013-07-25

ApplicantMr Instruments, Inc.
Decision Date2013-07-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUOFLEX COIL SUITE (1.5T) is the device name listed in this FDA 510(k) record. The listed applicant is Mr Instruments, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K130706. 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 (1.5T)?

DUOFLEX COIL SUITE (1.5T) is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Mr Instruments, Inc.. The 510(k) number is K130706.

When did DUOFLEX COIL SUITE (1.5T) receive FDA 510(k) clearance?

DUOFLEX COIL SUITE (1.5T) received FDA 510(k) clearance on 2013-07-25, under 510(k) number K130706.

Who is the listed applicant for DUOFLEX COIL SUITE (1.5T)?

The FDA 510(k) record lists Mr Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUOFLEX COIL SUITE (1.5T)?

The FDA product code for DUOFLEX COIL SUITE (1.5T) is MOS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mr Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173290DuoFLEX Coil SuiteK110591MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COILK080820TEM 3002G- HN DUAL TUNE HEAD COILK072931MC 3003G-32R HEAD COILK052200TEM 3000 HEAD COILK040937TEM 3000 HEAD COIL

View all 7 devices →

Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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.

↑