Device Classification Name |
System, X-Ray, Extraoral Source, Digital
|
510(k) Number |
K020588 |
Device Name |
X-IMAGE DIGITAL X-RAY SYSTEM |
Applicant |
ESCAPE TECHNOLOGY, INC. |
1530 BEACH ST. |
MONTEBELLO,
CA
90640
|
|
Applicant Contact |
JAY CHOI |
Correspondent |
ESCAPE TECHNOLOGY, INC. |
1530 BEACH ST. |
MONTEBELLO,
CA
90640
|
|
Correspondent Contact |
JAY CHOI |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 02/22/2002 |
Decision Date | 06/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|