Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K223267 |
Device Name |
SKR 3000 |
Applicant |
Konica Minolta, INC. |
1 Sakura-machi |
Hino-shi,
JP
191-8511
|
|
Applicant Contact |
Tsutomu Fukui |
Correspondent |
Konica Minolta Healthcare Americas, Inc. |
411 Newark Pompton Turnpike |
Wayne,
NJ
07470
|
|
Correspondent Contact |
Jan Maniscalco |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/24/2022 |
Decision Date | 11/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|