Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K120388 |
Device Name |
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
Applicant |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Applicant Contact |
EILEEN M BOYLE |
Correspondent |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
EILEEN M BOYLE |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 02/07/2012 |
Decision Date | 04/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|