Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K123526 |
Device Name |
CLEARREAD +CONFIRM |
Applicant |
RIVERAIN TECHNOLOGIES |
3020 SOUTH TECH BLVD. |
MIAMISBURG,
OH
45324
|
|
Applicant Contact |
JENNIFER BUTSCH |
Correspondent |
RIVERAIN TECHNOLOGIES |
3020 SOUTH TECH BLVD. |
MIAMISBURG,
OH
45324
|
|
Correspondent Contact |
JENNIFER BUTSCH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/15/2012 |
Decision Date | 12/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|