Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K142243 |
Device Name |
LessRay with Tracking |
Applicant |
SAFERAY SPINE, LLC |
5102 Durham Chapel Hill Blvd. Suite 203 |
Durham,
NC
27707
|
|
Applicant Contact |
Michael Alrutz |
Correspondent |
BIOLOGICS CONSULTING GROUP, INC. |
400 N. WASHINGTON STREET |
SUITE 100 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
Calley Herzog |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/13/2014 |
Decision Date | 11/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|