Vantage Elan
by Toshiba America Medical Systems, In.C
510(k) K141472
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141472 | Date19 Sep 2014 | 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- Withdrawn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 Elan is a System, Nuclear Magnetic Resonance Imaging (MRI) device, classified as a Class II medical device. It is designed for diagnostic imaging of the human body using magnetic resonance technology to generate detailed images of internal structures, aiding in the evaluation of anatomical and pathological conditions. The system operates by aligning hydrogen atoms in the body within a strong magnetic field and detecting the resulting radiofrequency signals to produce cross-sectional images.
The Vantage Elan is intended for use in radiology departments within clinical settings, where it is supplied as a reusable, non-sterile device. It is MRI-safe and must be operated in compliance with established electromagnetic interference (EMI) guidelines. The system is authorized under FDA 510(k) clearance (K141472) and falls under regulation 892.1000, with a product code of LNH. No specific sterility or single-use requirements are noted in the regulatory data.
Other devices from Toshiba America Medical Systems, In.C
See all devices from Toshiba America Medical Systems, In.C →
Questions
AI-generated answers, 1 Oct 2026
What is the Vantage Elan MRI system used for?
The Vantage Elan is a nuclear magnetic resonance imaging (MRI) system designed for diagnostic purposes in radiology departments. It generates detailed cross-sectional images of internal body structures by aligning hydrogen atoms in a strong magnetic field and detecting radiofrequency signals. This aids clinicians in evaluating anatomical and pathological conditions, such as soft tissue abnormalities, tumors, or musculoskeletal disorders.
How is the Vantage Elan MRI system supplied and what are its sterility requirements?
The Vantage Elan is supplied as a reusable, non-sterile device for use in clinical radiology settings. Since it is not classified as a sterile medical device, it does not require sterilization before or after use. However, it must be operated in compliance with electromagnetic interference (EMI) guidelines to ensure MRI safety and image integrity.
Is the Vantage Elan MRI system single-use or reusable?
The Vantage Elan is explicitly designed as a reusable device. It is not intended for single-use applications, and its construction and regulatory classification reflect its intended long-term use in clinical environments. Proper maintenance and adherence to manufacturer guidelines are essential for sustained performance and safety.
What regulatory approval does the Vantage Elan MRI system hold?
The Vantage Elan MRI system holds FDA 510(k) clearance under the reference number K141472. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness in its intended use for diagnostic imaging.
What safety considerations apply to the Vantage Elan MRI system?
The Vantage Elan is MRI-safe, meaning it is designed to operate without causing interference or harm in an MRI environment. However, it must be used in compliance with established electromagnetic interference (EMI) guidelines to prevent potential risks to patients and staff. These guidelines ensure the device functions correctly while minimizing exposure to stray magnetic fields or radiofrequency energy.