| Primary Device ID | 00859873006110 |
| NIH Device Record Key | 6229bb9b-ce22-4dc3-b1a5-8a9993039d59 |
| Commercial Distribution Discontinuation | 2025-01-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Voxel Dosimetry |
| Version Model Number | 1.0 |
| 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 |
| 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 | 2019-12-10Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps:
• SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS
• Registration of different time-points to a common reference study
• Generation and integration of voxel-level time-activity curves
• Voxel-level absorbed dose calculation using a Monte Carlo-method
• Saving of the absorbed dose-map back to GOLD or PACS in DICOM format.
Intended Use:
The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application.
Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes.
Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose. |
| 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 |
| 00859873006059 - HMS Medical Imaging Suite | 2018-07-06 HMS Medical Imaging Suite that provides software applications used to process, display, analyze and manage nuclear medicine and |