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

FDA 510(k) Regulatory Record - Hermes Medical Solutions AB Radiology ✕

16 devices

1-12 of 16

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

Radiology · 86d

Cleared Feb 14, 2020

Radiology · 93d

Cleared Oct 17, 2019

Voxel Dosimetry™ v1.0

Radiology · 164d

Cleared Oct 25, 2018

Radiology · 143d

Cleared Nov 21, 2017

Hermes Medical Imaging Suite v5.7

Radiology · 168d

Cleared Nov 21, 2017

Radiology · 165d

Cleared Jul 19, 2017

Radiology · 203d

Cleared May 22, 2017

Radiology · 168d

Cleared Jun 01, 2016

Hermes Medical Imaging Suite v5.6

Radiology · 224d