Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K011485 |
Device Name |
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER |
Applicant |
FONAR CORP. |
110 MARCUS DR., 102 MARCUS DR. |
& 405 SMITH ST. |
MELVILLE,
NY
11747
|
|
Applicant Contact |
LUCIANO BONANNI |
Correspondent |
FONAR CORP. |
110 MARCUS DR., 102 MARCUS DR. |
& 405 SMITH ST. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
LUCIANO BONANNI |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 05/15/2001 |
Decision Date | 06/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|