Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K990153 |
Device Name |
VIRGO MRI SYSTEM |
Applicant |
MILLENNIUM TECHNOLOGY SERVICES |
200 GREGORY LN., #C-100 |
PLEASANT HILL,
CA
|
|
Applicant Contact |
DAVID W SCHLERF |
Correspondent |
MILLENNIUM TECHNOLOGY SERVICES |
200 GREGORY LN., #C-100 |
PLEASANT HILL,
CA
|
|
Correspondent Contact |
DAVID W SCHLERF |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/19/1999 |
Decision Date | 10/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|