Hermia

GUDID 00859873006226

Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis. The software application can be configured based on user needs. The intended users of Voxel Dosimetry are medical professionals trained in using the system. Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Hermes Medical Solutions AB

Nuclear medicine system workstation

• Primary Device ID: 00859873006226
• NIH Device Record Key: efb24928-9253-4618-b4c3-d4a6e9ed881e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermia
• Version Model Number: 3
• Company DUNS: 354140220
• Company Name: Hermes Medical Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859873006226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243919

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-04
• Device Publish Date: 2025-08-27

Devices Manufactured by Hermes Medical Solutions AB

• 00859873006226 - Hermia: 2025-09-04Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis. The software application can be configured based on user needs. The intended users of Voxel Dosimetry are medical professionals trained in using the system. Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
• 00859873006226 - Hermia: 2025-09-04 Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map
• 00859873006172 - Affinity: 2023-07-11 Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and ana
• 00859873006158 - Hermes Medical Imaging Suite: 2022-02-15 Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and ot
• 00859873006165 - Affinity: 2022-02-15 AFFINITY is a software application used to process, display, analyze and manage nuclear medicine and other medical imaging data
• 00859873006141 - Affinity: 2021-01-19 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
• 00859873006134 - Affinity: 2020-03-04 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
• 00859873006110 - Voxel Dosimetry: 2019-12-10 Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™
• 00859873006035 - OLINDA/EXM: 2018-07-06 The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a