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FDA 510(k)

CAROTID COIL GE 1.5T

K-Number: K113280 · 2011-11-23

ApplicantTursiop Technologies, LLC
Decision Date2011-11-23
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAROTID COIL GE 1.5T is the device name listed in this FDA 510(k) record. The listed applicant is Tursiop Technologies, LLC. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K113280. 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 CAROTID COIL GE 1.5T?

CAROTID COIL GE 1.5T is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Tursiop Technologies, LLC. The 510(k) number is K113280.

When did CAROTID COIL GE 1.5T receive FDA 510(k) clearance?

CAROTID COIL GE 1.5T received FDA 510(k) clearance on 2011-11-23, under 510(k) number K113280.

Who is the listed applicant for CAROTID COIL GE 1.5T?

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

What is the FDA product code for CAROTID COIL GE 1.5T?

The FDA product code for CAROTID COIL GE 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 Tursiop Technologies, LLC 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.

K083434TT1 GENERAL PURPOSE COIL

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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