Hermes Medical Solutions AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
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
Hermes Medical Solutions AB has 17 FDA 510(k) cleared radiology devices. Based in Stockholm, SE.
Latest FDA clearance: Jul 2026. Active since 2012.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Hermes Medical Solutions AB
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
Cleared
Jun 01, 2016
Hermes Medical Imaging Suite v5.6
Radiology
224d
Cleared
Dec 18, 2014
Hermes Medical Imaging Suite v5.5
Radiology
92d
Cleared
May 08, 2014
HERMES MEDICAL IMAGING SUITE V5.4
Radiology
94d
Cleared
Jul 16, 2013
HERMES MEDICAL IMAGING SUITE V5.3
Radiology
76d
Cleared
Dec 18, 2012
HERMES MEDICAL IMAGING SUITE V5.2
Radiology
232d