Linear Shoulder Coil, Model 414GE-09
510(k) K991115
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991115 | Date8 Jun 1999 | 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- Withdrawn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
- MOS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Linear Shoulder Coil, Model 414GE-09 is a magnetic resonance imaging coil. It is designed for use in magnetic resonance imaging of the shoulder joint and surrounding tissue.
This device is manufactured by Medical Advances, Inc. and has received FDA 510(k) clearance. It is classified as a Class II device under regulation number 892.1000.
Other devices from Medical Advances, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary use of the Linear Shoulder Coil, Model 414GE-09?
This device is a magnetic resonance imaging (MRI) coil specifically designed for imaging the shoulder joint and its surrounding anatomical structures.
What is the regulatory status of this device?
The Linear Shoulder Coil, Model 414GE-09 has received FDA 510(k) clearance under the number K991115 and is classified as a Class II device under regulation number 892.1000.
Who is the manufacturer of this MRI coil?
The device is manufactured by Medical Advances, Inc., located in Milwaukee, Wisconsin.