Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K122298 |
Device Name |
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR |
Applicant |
AJEX MEDITECH., LTD |
52 NEWTOWN PLAZA |
PLAINVIEW,
NY
11803
|
|
Applicant Contact |
WILLIAM LITTLE |
Correspondent |
AJEX MEDITECH., LTD |
52 NEWTOWN PLAZA |
PLAINVIEW,
NY
11803
|
|
Correspondent Contact |
WILLIAM LITTLE |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 07/31/2012 |
Decision Date | 03/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|