Vantage Titan 3T, MRT-3010/A7, M-Power GX— 510(k) K172878

Substantially Equivalent

Toshiba Medical Systems Corporation, Japan

FDA 510(k) clearance K172878 for Vantage Titan 3T, MRT-3010/A7, M-Power GX, Substantially Equivalent on 2017-11-17. Applicant: Toshiba Medical Systems Corporation, Japan.

Clearance details

Applicant: Toshiba Medical Systems Corporation, Japan
Product code: Code LNH
Advisory panel: Radiology
Date received: 2017-09-21
Decision date: 2017-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.