Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K170755 |
Device Name |
DRX-Revolution Nano Mobile X-ray System |
Applicant |
Carestream Health, Inc. |
150 Verona Street |
Rochester,
NY
14608
|
|
Applicant Contact |
Victoria Wheeler |
Correspondent |
Carestream Health, Inc. |
150 Verona Street |
Rochester,
NY
14608
|
|
Correspondent Contact |
Victoria Wheeler |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 03/13/2017 |
Decision Date | 06/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|