Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K133174 |
Device Name |
ORTHOSCAN FD MINI C-ARM |
Applicant |
ORTHOSCAN, INC. |
8212 E Evans Rd |
8224 E Evans Rd |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
ADAM MENZIES |
Correspondent |
ORTHOSCAN, INC. |
8212 E Evans Rd |
8224 E Evans Rd |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
ADAM MENZIES |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/17/2013 |
Decision Date | 03/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|