Device Classification Name |
image-intensified fluoroscopic x-ray system, mobile
|
510(k) Number |
K050996 |
Device Name |
O-ARM IMAGING SYSTEM |
Applicant |
BREAKAWAY IMAGING, LLC |
300 FOSTER STREET |
LITTLETON,
MA
01460
|
|
Applicant Contact |
WOLFGANG KRULL |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
JEFF RONGERO |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 04/20/2005 |
Decision Date | 05/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|