Hermes Medical Solutions AB - FDA 510(k) Cleared Devices
Recent clearances: Hybrid Viewer (00859873006240), Voxel Dosimetry (00859873006226), Hybrid Viewer (00859873006189)
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hermes Medical Solutions AB Radiology ✕
17 devices
Cleared
Jul 31, 2026
Affinity
Radiology
242d
Cleared
Sep 09, 2025
Hybrid Viewer (00859873006240)
Radiology
33d
Cleared
Jul 30, 2025
Voxel Dosimetry (00859873006226)
Radiology
222d
Cleared
Nov 08, 2024
Hybrid Viewer (00859873006189)
Radiology
178d
Cleared
Dec 23, 2020
Affinity
Radiology
86d
Cleared
Feb 14, 2020
Affinity
Radiology
93d
Cleared
Oct 17, 2019
Voxel Dosimetry™ v1.0
Radiology
164d
Cleared
Oct 25, 2018
Hybrid3D
Radiology
143d
Cleared
Nov 21, 2017
Hermes Medical Imaging Suite v5.7
Radiology
168d
Cleared
Nov 21, 2017
Hybrid3D
Radiology
165d
Cleared
Jul 19, 2017
OLINDA EXM
Radiology
203d
Cleared
May 22, 2017
Hybrid3D
Radiology
168d