Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K162001 |
Device Name |
1.5T and 3.0T 16 CH GE Shoulder Coils |
Applicant |
INVIVO CORPORATION |
3545 SW 47TH AVE |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
KEN REVENNAUGH |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/20/2016 |
Decision Date | 08/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|