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FDA 510(k)

OPART, MODEL MRT-600

K-Number: K002522 · 2000-10-25

ApplicantToshiba America Mri, Inc.
Decision Date2000-10-25
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPART, MODEL MRT-600 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Mri, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K002522. 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 OPART, MODEL MRT-600?

OPART, MODEL MRT-600 is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K002522.

When did OPART, MODEL MRT-600 receive FDA 510(k) clearance?

OPART, MODEL MRT-600 received FDA 510(k) clearance on 2000-10-25, under 510(k) number K002522.

Who is the listed applicant for OPART, MODEL MRT-600?

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

What is the FDA product code for OPART, MODEL MRT-600?

The FDA product code for OPART, MODEL MRT-600 is MOS.

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Other records listing Toshiba America Mri, 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.

K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3K000549OPART, MODEL MRT-600K993803EXCELART WITH PIANISSIMOK993574OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGONK991740OPART, MODEL MRT-600K991057EXTRA LARGE BODY COIL FOR OPART (MRT-600)

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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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