Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K213780 |
Device Name |
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 |
Applicant |
Canon Inc. |
9-1 Imaikami-Cho, Nakahara-Ku |
Kawasaki,
JP
211-8501
|
|
Applicant Contact |
Akira Hirai |
Correspondent |
Ken Block Consulting |
800 East Campbell Drive, Suite 202 |
Richardson,
TX
75081
|
|
Correspondent Contact |
Gregory Woodard |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 12/02/2021 |
Decision Date | 01/24/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|