Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K130567 |
Device Name |
DR LONG LENGTH IMAGING SOFTWARE |
Applicant |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Applicant Contact |
CAROLYN WAGNER |
Correspondent |
CARESTREAM HEALTH, INC. |
150 VERONA STREET |
ROCHESTER,
NY
14608
|
|
Correspondent Contact |
CAROLYN WAGNER |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 03/04/2013 |
Decision Date | 06/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01592435
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|