Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K213307 |
Device Name |
Eclipse II with Smart Noise Cancellation |
Applicant |
Carestream Health, Inc. |
150 Verona St |
Rochester,
NY
14608
|
|
Applicant Contact |
Gina Maiolo |
Correspondent |
Carestream Health, Inc. |
150 Verona St |
Rochester,
NY
14608
|
|
Correspondent Contact |
Gina Maiolo |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 10/04/2021 |
Decision Date | 01/14/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|