Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K022307 |
Device Name |
KONRAD, MODEL V.2.0 |
Applicant |
MRC SYSTEMS GMBH |
HANS-BUNTE-STR. 10 |
HEIDELBERG,
DE
69123
|
|
Applicant Contact |
MARK-ALEKSI KELLER-REICHENBECHER |
Correspondent |
MRC SYSTEMS GMBH |
HANS-BUNTE-STR. 10 |
HEIDELBERG,
DE
69123
|
|
Correspondent Contact |
MARK-ALEKSI KELLER-REICHENBECHER |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/16/2002 |
Decision Date | 10/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|