Vantage Titan 1.5T, MRT-1510, V3.6 Software
by Toshibamedical Systems Corporation
510(k) K160632
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160632 | Date23 Aug 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vantage Titan 1.5T, MRT-1510, V3.6 Software is a System, Nuclear Magnetic Resonance Imaging device. It is classified as a Class II device with special controls. The device is used in the field of Radiology.
The device is supplied with software version V3.6 and is intended for use as specified by the manufacturer. It has been assigned a product code of LNH and a regulation number of 892.1000. The device received FDA 510(k) clearance on August 23, 2016.
Other devices from Toshiba Medical Systems
Questions
AI-generated answers, 1 Oct 2026
What is the Vantage Titan 1.5T used for?
The Vantage Titan 1.5T is used in the field of Radiology for Nuclear Magnetic Resonance Imaging.
What software version is the device supplied with?
The device is supplied with software version V3.6.
Is the Vantage Titan 1.5T a single-use or reusable device?
The device data does not specify whether the Vantage Titan 1.5T is single-use or reusable, but it is classified as a Class II device with special controls.
What is the product code and regulation number for the Vantage Titan 1.5T?
The product code is LNH and the regulation number is 892.1000.