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FDA 510(k)

Vantage Titan 1.5T, MRT-1510, V3.6 Software

K-Number: K160632 · 2016-08-23

Decision Date2016-08-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Titan 1.5T, MRT-1510, V3.6 Software is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K160632. 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 Vantage Titan 1.5T, MRT-1510, V3.6 Software?

Vantage Titan 1.5T, MRT-1510, V3.6 Software is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K160632.

When did Vantage Titan 1.5T, MRT-1510, V3.6 Software receive FDA 510(k) clearance?

Vantage Titan 1.5T, MRT-1510, V3.6 Software received FDA 510(k) clearance on 2016-08-23, under 510(k) number K160632.

Who is the listed applicant for Vantage Titan 1.5T, MRT-1510, V3.6 Software?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vantage Titan 1.5T, MRT-1510, V3.6 Software?

The FDA product code for Vantage Titan 1.5T, MRT-1510, V3.6 Software is LNH.

Other records listing Toshibamedical Systems Corporation 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.

View all 27 devices →

Related Devices (Code: LNH)

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.

Official Source

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