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FDA 510(k)

NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL

K-Number: K042103 · 2004-08-16

ApplicantMri Devices Corporation
Decision Date2004-08-16
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL 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 2004-08-16 under 510(k) number K042103. 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 NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL?

NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Mri Devices Corporation. The 510(k) number is K042103.

When did NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL receive FDA 510(k) clearance?

NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL received FDA 510(k) clearance on 2004-08-16, under 510(k) number K042103.

Who is the listed applicant for NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL?

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 NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL?

The FDA product code for NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL is MOS.

Related Clinical Trials

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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 COILK050514MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILSK050299HRK-123 KNEE 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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