Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K041695 |
Device Name |
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE |
Applicant |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Applicant Contact |
JAMES WRENN |
Correspondent |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Correspondent Contact |
JAMES WRENN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 06/22/2004 |
Decision Date | 07/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|