Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K942776 |
Device Name |
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1 |
Applicant |
OTSUKA ELECTRONICS USA, INC. |
2555 MIDPOINT DR. |
FORT COLLINS,
CO
80525
|
|
Applicant Contact |
G. NEIL HOLLAND |
Correspondent |
OTSUKA ELECTRONICS USA, INC. |
2555 MIDPOINT DR. |
FORT COLLINS,
CO
80525
|
|
Correspondent Contact |
G. NEIL HOLLAND |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 06/13/1994 |
Decision Date | 09/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|