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FDA 510(k)

SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS

K-Number: K112112 · 2011-08-25

ApplicantSentinel Medical, Inc.
Decision Date2011-08-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Medical, Inc.. It received FDA 510(k) clearance on 2011-08-25 under 510(k) number K112112. 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 SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS?

SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-08-25. The listed applicant is Sentinel Medical, Inc.. The 510(k) number is K112112.

When did SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS receive FDA 510(k) clearance?

SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS received FDA 510(k) clearance on 2011-08-25, under 510(k) number K112112.

Who is the listed applicant for SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS?

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

What is the FDA product code for SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS?

The FDA product code for SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS is MOS.

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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.

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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

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

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