Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K192512 |
Device Name |
Focus 35C Detector, Trimax 35C Detector |
Applicant |
iRay Technology Taicang Ltd. |
No.33 Xinggang Rd., Taicang Port Economic & |
Technological Development Zone |
Taicang,
CN
215434
|
|
Applicant Contact |
Meng Li |
Correspondent |
iRay Technology Taicang Ltd. |
No.33 Xinggang Rd., Taicang Port Economic & |
Technological Development Zone |
Taicang,
CN
215434
|
|
Correspondent Contact |
Meng Li |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/12/2019 |
Decision Date | 10/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|