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FDA 510(k)

FLEXART V3.1 SOFTWARE

K-Number: K962138 · 1996-12-23

ApplicantToshiba America Mri, Inc.
Decision Date1996-12-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXART V3.1 SOFTWARE 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 1996-12-23 under 510(k) number K962138. 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 FLEXART V3.1 SOFTWARE?

FLEXART V3.1 SOFTWARE is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K962138.

When did FLEXART V3.1 SOFTWARE receive FDA 510(k) clearance?

FLEXART V3.1 SOFTWARE received FDA 510(k) clearance on 1996-12-23, under 510(k) number K962138.

Who is the listed applicant for FLEXART V3.1 SOFTWARE?

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 FLEXART V3.1 SOFTWARE?

The FDA product code for FLEXART V3.1 SOFTWARE 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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