Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vantage Titan 3T, MRT-3010/A7, M-Power GX

K-Number: K172878 · 2017-11-17

Decision Date2017-11-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Titan 3T, MRT-3010/A7, M-Power GX is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Corporation, Japan. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172878. 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 3T, MRT-3010/A7, M-Power GX?

Vantage Titan 3T, MRT-3010/A7, M-Power GX is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K172878.

When did Vantage Titan 3T, MRT-3010/A7, M-Power GX receive FDA 510(k) clearance?

Vantage Titan 3T, MRT-3010/A7, M-Power GX received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172878.

Who is the listed applicant for Vantage Titan 3T, MRT-3010/A7, M-Power GX?

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

What is the FDA product code for Vantage Titan 3T, MRT-3010/A7, M-Power GX?

The FDA product code for Vantage Titan 3T, MRT-3010/A7, M-Power GX is LNH.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.