FDA 510(k)

1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM

K-Number: K123272 · 2013-03-28

Decision Date2013-03-28

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K123272. 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 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM?

1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Neocoil, LLC. The 510(k) number is K123272.

When did 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM receive FDA 510(k) clearance?

1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM received FDA 510(k) clearance on 2013-03-28, under 510(k) number K123272.

Who is the listed applicant for 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM?

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

What is the FDA product code for 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM?

The FDA product code for 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM is MOS.

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Related Devices (Code: MOS)

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, LLC K252587HD 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.