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FDA 510(k)

MARK III PHASED ARRAY SHOULDER COIL

K-Number: K042009 · 2004-08-11

ApplicantUsa Instruments, Inc.
Decision Date2004-08-11
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MARK III PHASED ARRAY SHOULDER COIL is the device name listed in this FDA 510(k) record. The listed applicant is Usa Instruments, Inc.. It received FDA 510(k) clearance on 2004-08-11 under 510(k) number K042009. 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 MARK III PHASED ARRAY SHOULDER COIL?

MARK III PHASED ARRAY SHOULDER COIL is a medical device that received FDA 510(k) clearance on 2004-08-11. The listed applicant is Usa Instruments, Inc.. The 510(k) number is K042009.

When did MARK III PHASED ARRAY SHOULDER COIL receive FDA 510(k) clearance?

MARK III PHASED ARRAY SHOULDER COIL received FDA 510(k) clearance on 2004-08-11, under 510(k) number K042009.

Who is the listed applicant for MARK III PHASED ARRAY SHOULDER COIL?

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

What is the FDA product code for MARK III PHASED ARRAY SHOULDER COIL?

The FDA product code for MARK III PHASED ARRAY SHOULDER COIL is MOS.

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Other records listing Usa Instruments, 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.

K052916USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAYK0525841.5T 12 CHANNEL BODY ARRAYK0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COILK0525853T HD BREAST ARRAYK050728OPEN BREAST COIL (OBC) WITH BIOPSY PLATESK042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL

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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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