| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|