Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K143176 |
Device Name |
UltraLinq |
Applicant |
ULTRALINQ HEALTHCARE SOLUTIONS, INC. |
236 West 30th Street, 15th Floor |
New York,
NY
10001
|
|
Applicant Contact |
Stephen Farber |
Correspondent |
MethodSense, Inc. |
PO Box 110352 |
Durham,
NC
27709
|
|
Correspondent Contact |
Rita King |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/04/2014 |
Decision Date | 07/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|