Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K193152 |
Device Name |
Affinity |
Applicant |
Hermes Medical Solutions AB |
Strandbergsgatan 16 |
Stockholm,
SE
11251
|
|
Applicant Contact |
Joakim Arwidson |
Correspondent |
Hermes Medical Solutions AB |
Strandbergsgatan 16 |
Stockholm,
SE
11251
|
|
Correspondent Contact |
Joakim Arwidson |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 11/13/2019 |
Decision Date | 02/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|