Model 455GE Phased Array Wrist Coil
510(k) K010074
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010074 | Date3 Apr 2001 | 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- Withdrawn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, 24 Sep 2026
A magnetic resonance diagnostic device intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be presented.
The device is supplied as a Class II MRI specialty coil for wrist imaging, cleared under FDA 510(k) K010074 in 2001. It is used in radiology settings and is not described as sterile, single-use, or reusable in the provided data. No information on MRI safety conditions, sizes, storage, or authorisations beyond the FDA 510(k) clearance is specified in the data.
Other devices from Medical Advances, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the MODEL 455GE PHASED ARRAY WRIST COIL used for?
The device is a magnetic resonance diagnostic device intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be presented.
How is the MODEL 455GE PHASED ARRAY WRIST COIL supplied and what is its regulatory classification?
The device is supplied as a Class II MRI specialty coil for wrist imaging, cleared under FDA 510(k) K010074 in 2001. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.
Is the MODEL 455GE PHASED ARRAY WRIST COIL described as sterile, single-use, or reusable in the provided data?
The device is not described as sterile, single-use, or reusable in the provided data. No information on sterility, single-use status, or reusability is specified in the device specifications or authorization details.