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FDA 510(k)

QUADRATURE WRIST COIL, MODEL 445PH-64

K-Number: K991434 · 1999-07-06

ApplicantMedical Advances, Inc.
Decision Date1999-07-06
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUADRATURE WRIST COIL, MODEL 445PH-64 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Advances, Inc.. It received FDA 510(k) clearance on 1999-07-06 under 510(k) number K991434. 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 QUADRATURE WRIST COIL, MODEL 445PH-64?

QUADRATURE WRIST COIL, MODEL 445PH-64 is a medical device that received FDA 510(k) clearance on 1999-07-06. The listed applicant is Medical Advances, Inc.. The 510(k) number is K991434.

When did QUADRATURE WRIST COIL, MODEL 445PH-64 receive FDA 510(k) clearance?

QUADRATURE WRIST COIL, MODEL 445PH-64 received FDA 510(k) clearance on 1999-07-06, under 510(k) number K991434.

Who is the listed applicant for QUADRATURE WRIST COIL, MODEL 445PH-64?

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

What is the FDA product code for QUADRATURE WRIST COIL, MODEL 445PH-64?

The FDA product code for QUADRATURE WRIST COIL, MODEL 445PH-64 is MOS.

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Other records listing Medical Advances, 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.

K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COILK021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COILK011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COILK010074MODEL 455GE PHASED ARRAY WRIST COILK003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COILK003144MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY 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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