Medical Device Manufacturer · SE , Stockholm

Hermes Medical Solutions AB

16 submissions · 16 cleared · Since 2012
16
Total
16
Cleared
0
Denied

Hermes Medical Solutions AB — FDA 510(k) Submissions

Hermes Medical Solutions AB has submitted 16 FDA 510(k) premarket notifications since 2012, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Tomography, Computed, Emission, Camera, Scintillation (gamma), System, Image Processing, Radiological, Automated Radiological Image Processing Software . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
Hybrid Viewer (00859873006240)
K252477 · KPS System, Tomography,... · Radiology
Sep 2025 33d
Voxel Dosimetry (00859873006226)
K243919 · QIH Automated Radiological... · Radiology
Jul 2025 222d
Hybrid Viewer (00859873006189)
K241364 · KPS System, Tomography,... · Radiology
Nov 2024 178d
Affinity
K202882 · KPS System, Tomography,... · Radiology
Dec 2020 86d
Affinity
K193152 · KPS System, Tomography,... · Radiology
Feb 2020 93d
Voxel Dosimetry? v1.0
K191216 · LLZ System, Image Processing,... · Radiology
Oct 2019 164d
Hybrid3D
K181468 · KPS System, Tomography,... · Radiology
Oct 2018 143d
Hermes Medical Imaging Suite v5.7
K171681 · KPS System, Tomography,... · Radiology
Nov 2017 168d
Hybrid3D
K171719 · KPS System, Tomography,... · Radiology
Nov 2017 165d
OLINDA EXM
K163687 · IYX Camera, Scintillation... · Radiology
Jul 2017 203d
Hybrid3D
K163394 · KPS System, Tomography,... · Radiology
May 2017 168d
Hermes Medical Imaging Suite v5.6
K153056 · KPS System, Tomography,... · Radiology
Jun 2016 224d
Hermes Medical Imaging Suite v5.5
K142631 · KPS System, Tomography,... · Radiology
Dec 2014 92d
HERMES MEDICAL IMAGING SUITE V5.4
K140269 · KPS System, Tomography,... · Radiology
May 2014 94d
HERMES MEDICAL IMAGING SUITE V5.3
K131233 · KPS System, Tomography,... · Radiology
Jul 2013 76d
HERMES MEDICAL IMAGING SUITE V5.2
K121278 · KPS System, Tomography,... · Radiology
Dec 2012 232d
Filters
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