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FDA 510(k)

OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE

K-Number: K981475 · 1998-07-14

ApplicantToshiba America Mri, Inc.
Decision Date1998-07-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE 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 1998-07-14 under 510(k) number K981475. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE?

OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K981475.

When did OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE receive FDA 510(k) clearance?

OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE received FDA 510(k) clearance on 1998-07-14, under 510(k) number K981475.

Who is the listed applicant for OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE?

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 (MRT-600) VERSIONS 2 SOFTWARE UPGRADE?

The FDA product code for OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE is LNH.

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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/P3K002522OPART, MODEL MRT-600K000549OPART, MODEL MRT-600K993803EXCELART WITH PIANISSIMOK993574OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGONK991740OPART, MODEL MRT-600

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Related Devices (Code: LNH)

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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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