Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K161322 |
Device Name |
CT CoPilot |
Applicant |
ZEPMED, LLC. |
2465 Avenida de La Playa |
La Jolla,
CA
92037
|
|
Applicant Contact |
Douglas J. Bates |
Correspondent |
MONROE MEDICAL DEVICE CONSULTING, LLC |
319 Shilling Dr |
Somerset,
NJ
08873
|
|
Correspondent Contact |
James W. Monroe |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/11/2016 |
Decision Date | 12/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|