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FDA 510(k)

SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM

K-Number: K961842 · 1996-08-02

ApplicantToshiba America Mri, Inc.
Decision Date1996-08-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM 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 1996-08-02 under 510(k) number K961842. 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 SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM?

SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K961842.

When did SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM receive FDA 510(k) clearance?

SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM received FDA 510(k) clearance on 1996-08-02, under 510(k) number K961842.

Who is the listed applicant for SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM?

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 SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM?

The FDA product code for SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM 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.

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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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