Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K191267 |
Device Name |
ImagingRing System on Rails |
Applicant |
MedPhoton GmbH |
Strubergasse 16 |
Salzburg,
AT
5020
|
|
Applicant Contact |
Daniel Schaffarzick |
Correspondent |
MedPhoton GmbH |
Strubergasse 16 |
Salzburg,
AT
5020
|
|
Correspondent Contact |
Daniel Schaffarzick |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 05/10/2019 |
Decision Date | 08/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|