Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K201528 |
Device Name |
Yushan X-Ray Flat Panel Detector with DROC |
Applicant |
InnoCare Optoelectronics Corp. |
Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., |
Tainan City 744, Taiwan (R.O.C.) |
Tainan City,
TW
744
|
|
Applicant Contact |
Yumei Cheng |
Correspondent |
InnoCare Optoelectronics Corp. |
Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., |
Tainan City 744, Taiwan (R.O.C.) |
Tainan City,
TW
744
|
|
Correspondent Contact |
Yumei Cheng |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 06/08/2020 |
Decision Date | 10/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|