Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K031198 |
Device Name |
SCANX 10 |
Applicant |
AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. |
HICKSVILLE,
NY
11801
|
|
Applicant Contact |
JOSEPH CAREY |
Correspondent |
AIR TECHNIQUES, INC. |
70 CANTIAGUE ROCK RD. |
HICKSVILLE,
NY
11801
|
|
Correspondent Contact |
JOSEPH CAREY |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 04/16/2003 |
Decision Date | 06/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|