Hermia
Basic Information
- Brand Name
- Hermia
- Primary DI
- 00859873006226
- Version / Model
- 00859873006226
- Company Name
- Hermes Medical Solutions AB
- Labeler DUNS
- 354140220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-27
- Public Version
- 2
- Public Version Date
- 2026-03-06
- Public Version Status
- Update
- Public Device Record Key
- efb24928-9253-4618-b4c3-d4a6e9ed881e
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40937 | Nuclear medicine system workstation | A freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859873006226 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243919 | 000 |