| Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
| 510(k) Number |
K920204 |
| Device Name |
INSTASCAN |
| Applicant |
| Advanced Nmr Systems, Inc. |
| Columbia Sq. |
| 555 Thirteenth St., NW |
|
Washington, D.C.,
DC
20004
|
|
| Applicant Contact |
JONATHAN S KAHAN |
| Correspondent |
| Advanced Nmr Systems, Inc. |
| Columbia Sq. |
| 555 Thirteenth St., NW |
|
Washington, D.C.,
DC
20004
|
|
| Correspondent Contact |
JONATHAN S KAHAN |
| Regulation Number | 892.1000 |
| Classification Product Code |
|
| Date Received | 01/16/1992 |
| Decision Date | 08/05/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|