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FDA 510(k)

MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS

K-Number: K050514 · 2005-03-25

ApplicantMri Devices Corporation
Decision Date2005-03-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS is the device name listed in this FDA 510(k) record. The listed applicant is Mri Devices Corporation. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050514. 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 MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS?

MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Mri Devices Corporation. The 510(k) number is K050514.

When did MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS receive FDA 510(k) clearance?

MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050514.

Who is the listed applicant for MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS?

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

What is the FDA product code for MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS?

The FDA product code for MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS is MOS.

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Other records listing Mri Devices Corporation 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.

K050622HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COILK050621NVA-127-8-A NEUROVASCULAR ARRAY COILK050299HRK-123 KNEE ARRAY COILK042103NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY 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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