Syngo MR 2002B
by Siemens Medical Solutions USA, Inc.
510(k) K020991
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020991 | Date13 Jun 2002 | StatusActive |
Recalls
-
- Terminated Z-0175-03
Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
-
- Terminated Z-1087-03
software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
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- Withdrawn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 Syngo MR 2002B is a Magnetic Resonance Imaging (MRI) System designed for diagnostic imaging. It acquires magnetic resonance signals to generate cross-sectional images and spectroscopic data of the head, body, and extremities, enabling detailed visualization for clinical assessment.
This device is intended for use in radiology settings as a software and hardware upgrade for existing Siemens MAGNETOM MRI systems. It is classified as a Class II medical device under FDA regulations (510(k) clearance K020991) and is not described as single-use or reusable. No specific MRI safety classification or sterility requirements are stated in the provided data.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Syngo MR 2002B used for?
The Syngo MR 2002B is a software upgrade designed for Siemens MAGNETOM MRI systems. It enhances diagnostic imaging by acquiring magnetic resonance signals to generate detailed cross-sectional images and spectroscopic data of the head, body, and extremities. This allows clinicians to visualize internal structures with high precision for accurate clinical assessment.
How is the Syngo MR 2002B supplied and installed?
The Syngo MR 2002B is supplied as a software upgrade package for existing Siemens MAGNETOM MRI systems. It is not a standalone device but rather an enhancement to the existing hardware. Installation involves integrating the software into the system’s operating environment, typically requiring technical support from Siemens or authorized service providers to ensure compatibility and proper functionality.
Is the Syngo MR 2002B single-use or reusable?
The Syngo MR 2002B is not described as single-use or reusable in the provided data. As a software upgrade, it is intended for repeated use within the MRI system it is installed on, provided the system remains operational and maintained according to manufacturer guidelines.
Are there any specific sterility or safety requirements for the Syngo MR 2002B?
The Syngo MR 2002B software upgrade does not have specific sterility requirements since it is not a physical device that comes into direct contact with patients. However, MRI safety protocols must still be followed during use, as the upgrade operates within an MRI environment. Always adhere to the manufacturer’s guidelines and local regulations for MRI safety.
What types of Siemens MRI systems is the Syngo MR 2002B compatible with?
The Syngo MR 2002B is designed as an upgrade for existing Siemens MAGNETOM MRI systems. While the exact models are not specified in the provided data, compatibility is typically determined by the system’s software architecture and hardware specifications. Siemens provides compatibility lists and installation guidelines to ensure the upgrade works seamlessly with supported systems.