Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K994282 |
Device Name |
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE |
Applicant |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
POORTGEBOUW RIJNSBURGERWEG 10 |
LEIDEN,
NL
2333 AA
|
|
Applicant Contact |
J.I. HOLLANDER |
Correspondent |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
POORTGEBOUW RIJNSBURGERWEG 10 |
LEIDEN,
NL
2333 AA
|
|
Correspondent Contact |
J.I. HOLLANDER |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 12/20/1999 |
Decision Date | 03/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|