Liberty 9000 Breast Coil
by USA Instruments, Inc. United States 510(k)
510(k) K000993 Product code MOS
Overview
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 specialty coil for magnetic resonance imaging, with authorization under FDA 510(k) clearance K000993, classified as a Class II device under regulation number 892.1000, and identified by product code MOS. It is manufactured by USA Instruments, Inc. and was cleared on May 26, 2000.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000993 | Date26 May 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from USA Instruments, Inc.
Questions
What is the LIBERTY 9000 BREAST COIL used for?
The LIBERTY 9000 BREAST COIL is a magnetic resonance diagnostic device intended for general diagnostic use to present images reflecting the spatial distribution and/or magnetic resonance spectra reflecting frequency and distribution of nuclei exhibiting nuclear magnetic resonance, with other physical parameters derived from the images and/or spectra also presented.
How is the LIBERTY 9000 BREAST COIL supplied and what is its regulatory classification?
The device is supplied as a specialty coil for magnetic resonance imaging, has FDA 510(k) clearance K000993, is classified as a Class II device under regulation number 892.1000, and is identified by product code MOS.
Who manufactures the LIBERTY 9000 BREAST COIL and when was it cleared?
The LIBERTY 9000 BREAST COIL is manufactured by USA Instruments, Inc. and received FDA 510(k) clearance on May 26, 2000, following a traditional submission process after being received on March 28, 2000.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K000993