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FDA 510(k)

HRB-127-32 HIGH RESOLUTION BRAIN COIL

K-Number: K082916 · 2008-10-15

ApplicantInvivo
Decision Date2008-10-15
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HRB-127-32 HIGH RESOLUTION BRAIN COIL is the device name listed in this FDA 510(k) record. The listed applicant is Invivo. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K082916. 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 HRB-127-32 HIGH RESOLUTION BRAIN COIL?

HRB-127-32 HIGH RESOLUTION BRAIN COIL is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Invivo. The 510(k) number is K082916.

When did HRB-127-32 HIGH RESOLUTION BRAIN COIL receive FDA 510(k) clearance?

HRB-127-32 HIGH RESOLUTION BRAIN COIL received FDA 510(k) clearance on 2008-10-15, under 510(k) number K082916.

Who is the listed applicant for HRB-127-32 HIGH RESOLUTION BRAIN COIL?

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

What is the FDA product code for HRB-127-32 HIGH RESOLUTION BRAIN COIL?

The FDA product code for HRB-127-32 HIGH RESOLUTION BRAIN COIL 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.

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Other records listing Invivo 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.

K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COILK072873LBS-63-16 BREAST ARRAY COILK072874LBS-127-16 BREAST ARRAY COILK061952CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16

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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