Device Classification Name |
System, X-Ray, Extraoral Source, Digital
|
510(k) Number |
K121800 |
Device Name |
POINT 500 HD POINT500C HD |
Applicant |
POINTNIX CO., LTD |
55 NORTHERN BLVD |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
JIGAR SHAH |
Correspondent |
POINTNIX CO., LTD |
55 NORTHERN BLVD |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
JIGAR SHAH |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 06/19/2012 |
Decision Date | 01/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|