Quadrature Small Extremity Coil
510(k) K935015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935015 | Date10 May 1994 | 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- Withdrawn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, 27 Sep 2026
The Quadrature Small Extremity Coil is a system for nuclear magnetic resonance imaging. It functions as a specialized coil designed to facilitate imaging of small extremities within a magnetic resonance environment.
This device is manufactured by Magnetic Research, Inc. and received FDA 510(k) clearance on May 10, 1994, under reference number K935015.
Other devices from Magnetic Research, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary purpose of the Quadrature Small Extremity Coil?
This device is a specialized coil system engineered to facilitate nuclear magnetic resonance imaging specifically for small extremities within a magnetic resonance environment.
Who is the manufacturer of this imaging coil?
The Quadrature Small Extremity Coil is manufactured by Magnetic Research, Inc., based in Provo, Utah.
What is the regulatory status of this device?
The device received FDA 510(k) clearance on May 10, 1994, under reference number K935015, after being determined to be substantially equivalent to existing devices.