Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K131431 |
Device Name |
AIRO CT SYSTEM |
Applicant |
MOBIUS IMAGING, LLC |
323 WEST MAIN STREET |
AYER,
MA
01432
|
|
Applicant Contact |
NORMA LEMAY |
Correspondent |
MOBIUS IMAGING, LLC |
323 WEST MAIN STREET |
AYER,
MA
01432
|
|
Correspondent Contact |
NORMA LEMAY |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 05/17/2013 |
Decision Date | 09/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|