Mobile MRP-20 Magnetic Resonance Diagnostic Device
510(k) K901980
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901980 | Date28 Jun 1990 | 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- Withdrawn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 Mobile MRP-20 Magnetic Resonance Diagnostic Device is a Class II MRI scanner system used for diagnostic imaging in radiology. It is designed to provide nuclear magnetic resonance imaging capabilities in a mobile configuration.
The device is manufactured by Summit World Trade Corp. and is supplied as a mobile unit. It received FDA 510(k) clearance with K number K901980 on June 28, 1990, and is regulated under product code LNH. The device is intended for use in radiology settings.
Other devices from Summit World Trade Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Mobile MRP-20 Magnetic Resonance Diagnostic Device used for?
The Mobile MRP-20 is a Class II MRI scanner system designed for diagnostic imaging in radiology. It provides nuclear magnetic resonance imaging capabilities in a mobile configuration, allowing for flexible imaging solutions in various healthcare settings.
How is the Mobile MRP-20 MRI device supplied?
The Mobile MRP-20 Magnetic Resonance Diagnostic Device is supplied as a complete mobile unit by Summit World Trade Corp. It is designed to be transported and set up at different locations as needed for diagnostic imaging procedures.
What regulatory approvals does the Mobile MRP-20 MRI have?
The Mobile MRP-20 received FDA 510(k) clearance with K number K901980 on June 28, 1990. It is regulated under product code LNH and is classified as substantially equivalent to predicate devices for nuclear magnetic resonance imaging systems.
What are the specifications of the Mobile MRP-20 MRI device?
The Mobile MRP-20 is a mobile MRI scanner system intended for use in radiology settings. It is a Class II device that provides nuclear magnetic resonance imaging capabilities. The device was manufactured by Summit World Trade Corp. and received FDA clearance through the traditional 510(k) pathway.