FDA 510(k)

PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL

K-Number: K031366 · 2003-07-11

Decision Date2003-07-11

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE 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 2003-07-11 under 510(k) number K031366. 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 PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL?

PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Usa Instruments, Inc.. The 510(k) number is K031366.

When did PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL receive FDA 510(k) clearance?

PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL received FDA 510(k) clearance on 2003-07-11, under 510(k) number K031366.

Who is the listed applicant for PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE 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 PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL?

The FDA product code for PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL is MOS.

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Other records listing Usa Instruments, Inc. as applicant

K052916USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY K0525841.5T 12 CHANNEL BODY ARRAY K0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL K0525853T HD BREAST ARRAY K050728OPEN BREAST COIL (OBC) WITH BIOPSY PLATES K042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL

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Related Devices (Code: MOS)

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, LLC K252587HD 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.