Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K182550 |
Device Name |
Wireless Digital Flat Panel 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 | 09/17/2018 |
Decision Date | 10/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|