Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K083255 |
Device Name |
16CH AI BREAST COILS 1.5 T AND 3 T |
Applicant |
RAPID BIOMEDICAL GMBH |
KETTELERSTRASSE 3-11 |
RIMPAR, BAYERN,
DE
97222
|
|
Applicant Contact |
ARMIN PUREA |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/04/2008 |
Decision Date | 11/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|