Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K182050 |
Device Name |
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard, Mail Code 65-1A |
Malvern,
PA
19355
|
|
Applicant Contact |
Martin Rajchel |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard, Mail Code 65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Martin Rajchel |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/31/2018 |
Decision Date | 10/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|