Device Classification Name |
System, X-Ray, Mammographic
|
510(k) Number |
K011987 |
Device Name |
MODIFIED M-IV MAMMOGRAPHY SYSTEM |
Applicant |
LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. |
DANBURY,
CT
06810
|
|
Applicant Contact |
ROAIDA RIZKALLAH |
Correspondent |
LORAD, A HOLOGIC CO. |
36 APPLE RIDGE RD. |
DANBURY,
CT
06810
|
|
Correspondent Contact |
ROAIDA RIZKALLAH |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 06/26/2001 |
Decision Date | 07/11/2001 |
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
|
|
|