EchoStar Spica 1.5T MR System
by Alltech Medical Systems America, Inc.
510(k) K113511
Active
Valid until
Not listed
FDA recalls
None ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK113511 | Date2 May 2012 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Terminated Z-1061-2015
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The EchoStar Spica 1.5T MR System is a superconducting magnetic resonance imaging (MRI) system designed for nuclear magnetic resonance imaging. It generates detailed images of the human body’s internal structures using a 1.5-tesla magnetic field, enabling diagnostic evaluation of soft tissues, organs, and musculoskeletal systems.
This system is intended for use in radiology departments and clinical settings, supplied as a fully integrated MRI solution. It is regulated under the FDA 510(k) pathway with a determination of substantial equivalence to a predicate device, and complies with the Medical Device Directive (MDD). The system is not described as single-use or reusable, and no specific sterility or MRI safety classifications are provided in the data.
Other devices from Alltech Medical Systems America, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the EchoStar Spica 1.5T MR System in a clinical setting?
The EchoStar Spica 1.5T MR System is designed for nuclear magnetic resonance imaging (MRI) to generate detailed images of the human body’s internal structures. It is specifically used for diagnostic evaluation of soft tissues, organs, and musculoskeletal systems, making it ideal for radiology departments and clinical settings where high-resolution imaging is required.
How is the EchoStar Spica 1.5T MR System regulated, and what does that mean for potential buyers?
The EchoStar Spica 1.5T MR System is regulated under the FDA 510(k) pathway, with a determination of substantial equivalence to a predicate device. This means it has been reviewed and cleared by the FDA as safe and effective for its intended use, and it also complies with the Medical Device Directive (MDD) in Europe. Buyers can rely on this regulatory clearance as part of their due diligence when evaluating the system’s compliance and suitability for their facility.
Is the EchoStar Spica 1.5T MR System intended for single-use or repeated use, and what does that imply for maintenance?
The provided data does not specify whether the EchoStar Spica 1.5T MR System is single-use or reusable. As an integrated MRI solution, it is likely designed for repeated use in clinical settings, which implies that maintenance, calibration, and servicing will be required to ensure consistent performance and safety over time. Buyers should confirm maintenance requirements directly with the manufacturer.
What magnetic field strength does the EchoStar Spica 1.5T MR System use, and how does that affect its diagnostic capabilities?
The EchoStar Spica 1.5T MR System operates at a 1.5-tesla magnetic field strength, which is a standard field strength for MRI systems. This strength provides a balance between image resolution and safety, enabling detailed visualization of soft tissues, organs, and musculoskeletal structures. Higher field strengths (like 1.5T) generally offer better contrast resolution compared to lower-field systems, making it suitable for a wide range of diagnostic evaluations.