Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K171085 |
Device Name |
GMR40 |
Applicant |
NeuroLogica Corporation, a Subsidiary of |
Samsung Electronics Co., Ltd |
14 Electronics Avenue |
Danvers,
MA
01923
|
|
Applicant Contact |
Ninad Gujar |
Correspondent |
NeuroLogica Corporation, a Subsidiary of |
Samsung Electronics Co., Ltd |
14 Electronics Avenue |
Danvers,
MA
01923
|
|
Correspondent Contact |
Ninad Gujar |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 04/12/2017 |
Decision Date | 05/11/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|