Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K143485 |
Device Name |
iGuide 2.1 |
Applicant |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
ROBERT-BOSCH-STRASSE 8 |
SCHWABMUNCHEN,
DE
86830
|
|
Applicant Contact |
MICHAEL WOLFF |
Correspondent |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
ROBERT-BOSCH-STRASSE 8 |
SCHWABMUNCHEN,
DE
86830
|
|
Correspondent Contact |
MICHAEL WOLFF |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 12/08/2014 |
Decision Date | 03/04/2015 |
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
|
|
|