Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K161973 |
Device Name |
G-scan Brio, S-scan |
Applicant |
Esaote S.p.A. |
Via Siffredi 58 |
Genova,
IT
16153
|
|
Applicant Contact |
Maria Marzapane |
Correspondent |
Navigant Consulting, Inc. |
9001 Wesleyan Road, Suite 200 |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
Allison Scott |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/18/2016 |
Decision Date | 10/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|