Medical Device Manufacturer · SE , Stockholm

Hermes Medical Solutions AB - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2012

Recent clearances: Hybrid Viewer (00859873006240), Voxel Dosimetry (00859873006226), Hybrid Viewer (00859873006189)

16
Total
16
Cleared
0
Denied

Hermes Medical Solutions AB has 16 FDA 510(k) cleared radiology devices. Based in Stockholm, SE.

Latest FDA clearance: Sep 2025. 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

16 devices
1-16 of 16
Cleared Sep 09, 2025
Hybrid Viewer (00859873006240)
K252477 · KPS
Radiology · 33d
Cleared Jul 30, 2025
Voxel Dosimetry (00859873006226)
K243919 · QIH
Radiology · 222d
Cleared Nov 08, 2024
Hybrid Viewer (00859873006189)
K241364 · KPS
Radiology · 178d
Cleared Dec 23, 2020
Affinity
K202882 · KPS
Radiology · 86d
Cleared Feb 14, 2020
Affinity
K193152 · KPS
Radiology · 93d
Cleared Oct 17, 2019
Voxel Dosimetry™ v1.0
K191216 · LLZ
Radiology · 164d
Cleared Oct 25, 2018
Hybrid3D
K181468 · KPS
Radiology · 143d
Cleared Nov 21, 2017
Hermes Medical Imaging Suite v5.7
K171681 · KPS
Radiology · 168d
Cleared Nov 21, 2017
Hybrid3D
K171719 · KPS
Radiology · 165d
Cleared Jul 19, 2017
OLINDA EXM
K163687 · IYX
Radiology · 203d
Cleared May 22, 2017
Hybrid3D
K163394 · KPS
Radiology · 168d
Cleared Jun 01, 2016
Hermes Medical Imaging Suite v5.6
K153056 · KPS
Radiology · 224d
Cleared Dec 18, 2014
Hermes Medical Imaging Suite v5.5
K142631 · KPS
Radiology · 92d
Cleared May 08, 2014
HERMES MEDICAL IMAGING SUITE V5.4
K140269 · KPS
Radiology · 94d
Cleared Jul 16, 2013
HERMES MEDICAL IMAGING SUITE V5.3
K131233 · KPS
Radiology · 76d
Cleared Dec 18, 2012
HERMES MEDICAL IMAGING SUITE V5.2
K121278 · KPS
Radiology · 232d
Filters
Filter by Specialty
All16 Radiology 16