Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K052585 |
Device Name |
3T HD BREAST ARRAY |
Applicant |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Applicant Contact |
DAVID BROWN |
Correspondent |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Correspondent Contact |
DAVID BROWN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 09/20/2005 |
Decision Date | 10/04/2005 |
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
|
|
|