Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K192922 |
Device Name |
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter |
Applicant |
Gentuity, LLC |
142 North Road, Suite G |
Sudbury,
MA
01776
|
|
Applicant Contact |
David Kolstad |
Correspondent |
Mandell Horwitz Consultants LLC |
5 Lake Como Ct. |
Greenville,
SC
29609
|
|
Correspondent Contact |
Diane Horwitz |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/16/2019 |
Decision Date | 02/20/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|