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FDA 510(k)

TEM 3000 HEAD COIL

K-Number: K052200 · 2005-08-19

ApplicantMr Instruments, Inc.
Decision Date2005-08-19
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TEM 3000 HEAD COIL 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 2005-08-19 under 510(k) number K052200. 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 TEM 3000 HEAD COIL?

TEM 3000 HEAD COIL is a medical device that received FDA 510(k) clearance on 2005-08-19. The listed applicant is Mr Instruments, Inc.. The 510(k) number is K052200.

When did TEM 3000 HEAD COIL receive FDA 510(k) clearance?

TEM 3000 HEAD COIL received FDA 510(k) clearance on 2005-08-19, under 510(k) number K052200.

Who is the listed applicant for TEM 3000 HEAD COIL?

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 TEM 3000 HEAD COIL?

The FDA product code for TEM 3000 HEAD COIL is MOS.

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 SuiteK130706DUOFLEX COIL SUITE (1.5T)K110591MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COILK080820TEM 3002G- HN DUAL TUNE HEAD COILK072931MC 3003G-32R HEAD COILK040937TEM 3000 HEAD COIL

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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.

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