Device Classification Name |
System, Planning, Radiation Therapy Treatment
|
510(k) Number |
K192065 |
Device Name |
Syngo.Via RT Image Suite |
Applicant |
Siemens Medical Solutions USA, Inc. |
2501 N Barrington Rd. |
Hoffman Estates,
IL
60192
|
|
Applicant Contact |
Veronica Padharia |
Correspondent |
Siemens Medical Solutions USA, Inc. |
2501 N Barrington Rd. |
Hoffman Estates,
IL
60192
|
|
Correspondent Contact |
Veronica Padharia |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 08/01/2019 |
Decision Date | 09/18/2019 |
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
|
|
|