Device Classification Name |
X-Ray, Tomography, Computed, Dental
|
510(k) Number |
K192737 |
Device Name |
RCT800 |
Applicant |
RAY CO., Ltd |
332-7, Samsung 1-ro |
Hwaseong-si,
KR
18380
|
|
Applicant Contact |
Changhwan Lee |
Correspondent |
RAY CO., Ltd |
332-7, Samsung 1-ro |
Hwaseong-si,
KR
18380
|
|
Correspondent Contact |
Changhwan Lee |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 09/27/2019 |
Decision Date | 10/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|