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FDA 510(k)

MODIFICATION TO: QWH-420 WRIST ARRAY COIL

K-Number: K013099 · 2001-09-25

ApplicantMri Devices Corp.
Decision Date2001-09-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: QWH-420 WRIST ARRAY COIL is the device name listed in this FDA 510(k) record. The listed applicant is Mri Devices Corp.. It received FDA 510(k) clearance on 2001-09-25 under 510(k) number K013099. 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 MODIFICATION TO: QWH-420 WRIST ARRAY COIL?

MODIFICATION TO: QWH-420 WRIST ARRAY COIL is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is Mri Devices Corp.. The 510(k) number is K013099.

When did MODIFICATION TO: QWH-420 WRIST ARRAY COIL receive FDA 510(k) clearance?

MODIFICATION TO: QWH-420 WRIST ARRAY COIL received FDA 510(k) clearance on 2001-09-25, under 510(k) number K013099.

Who is the listed applicant for MODIFICATION TO: QWH-420 WRIST ARRAY COIL?

The FDA 510(k) record lists Mri Devices Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: QWH-420 WRIST ARRAY COIL?

The FDA product code for MODIFICATION TO: QWH-420 WRIST ARRAY COIL is MOS.

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Other records listing Mri Devices Corp. 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.

K041286DYNACAD V1.0K041481MODEL BBC-127 BIOPSY BREAST COILK040348MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COILK040349MODIFICATION TO HRW-127 WRIST ARRAY COILK040288QSC-127-INT SHOULDER ARRAY COIL SETK033447CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376

View all 71 devices →

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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