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FDA 510(k)

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

K-Number: K123091 · 2012-12-27

ApplicantImris, Inc.
Decision Date2012-12-27
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K123091. 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 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T?

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Imris, Inc.. The 510(k) number is K123091.

When did VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T receive FDA 510(k) clearance?

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T received FDA 510(k) clearance on 2012-12-27, under 510(k) number K123091.

Who is the listed applicant for VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T?

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

What is the FDA product code for VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T?

The FDA product code for VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T is MOS.

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Other records listing Imris, 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.

K130224ICTK121997IMRIS ONCOLOGY PACKAGEK113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)K103493HEAD FIATION DEVICE (HFD 100)K1035061.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)K101813IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

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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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