Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K003651 |
Device Name |
AURORA |
Applicant |
AURORA IMAGING TECHNOLOGY, INC. |
46 JONSPIN RD. |
WILMINGTON,
MA
01887
|
|
Applicant Contact |
JAMES J ROGERS |
Correspondent |
AURORA IMAGING TECHNOLOGY, INC. |
46 JONSPIN RD. |
WILMINGTON,
MA
01887
|
|
Correspondent Contact |
JAMES J ROGERS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/27/2000 |
Decision Date | 02/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|