E-Scan XQ
by Biosound Esaote, Inc. 510(k)
Active
510(k) K020164
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020164 | Date12 Feb 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 22 Sep 2026
The E-Scan XQ is a nuclear magnetic resonance imaging system designed for diagnostic imaging. It produces transverse, sagittal, coronal, and oblique cross-sectional images of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, and forearm.
This device is manufactured by Biosound Esaote, Inc. and is regulated under FDA 510(k) authorization. It is classified as a Class II medical device within the radiology specialty.
Other devices from Biosound Esaote, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the E-Scan XQ used for?
The E-Scan XQ is a nuclear magnetic resonance imaging system designed to produce diagnostic cross-sectional images, including transverse, sagittal, coronal, and oblique views of the extremities, such as the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, and forearm.
How is this device regulated?
The E-Scan XQ is classified as a Class II medical device within the radiology specialty and is regulated under FDA 510(k) authorization, which indicates it has been found to be substantially equivalent to other legally marketed devices.
Who is the manufacturer of the E-Scan XQ?
The E-Scan XQ is manufactured by Biosound Esaote, Inc., located in Indianapolis, Indiana.