FDA 510(k)

SYNERGY SPINE ARRAY COIL

K-Number: K033662 · 2004-02-02

Decision Date2004-02-02

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SYNERGY SPINE ARRAY COIL is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K033662. 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 SYNERGY SPINE ARRAY COIL?

SYNERGY SPINE ARRAY COIL is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K033662.

When did SYNERGY SPINE ARRAY COIL receive FDA 510(k) clearance?

SYNERGY SPINE ARRAY COIL received FDA 510(k) clearance on 2004-02-02, under 510(k) number K033662.

Who is the listed applicant for SYNERGY SPINE ARRAY COIL?

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

What is the FDA product code for SYNERGY SPINE ARRAY COIL?

The FDA product code for SYNERGY SPINE ARRAY COIL is MOS.

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Other records listing Philips Medical Systems, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.