Identifiers
- 510(k) Number
- K191216 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Voxel Dosimetry v1.0 is a clinical software tool designed for voxel-based dose calculations in radiopharmaceutical therapy. It specializes in quantifying radiation dose distributions within patient anatomy, particularly for internal radiation sources administered via approved radiopharmaceuticals. The system leverages volumetric imaging data to enable precise dose assessment in organs such as the liver, kidneys, spleen, and lungs. This aids in personalized treatment planning and monitoring for patients undergoing radiopharmaceutical-based therapies.
The software is supplied as a standalone application for use in clinical settings, requiring compatibility with imaging systems and radiopharmaceutical data. It is intended for single-use per patient dose calculation, though the software itself may be reused across multiple cases. No sterility or physical packaging requirements are specified, as it operates digitally. Authorized under FDA 510(k) clearance (K191216) as substantially equivalent to a predicate device, it adheres to regulatory standards for radiology-related software. No MRI safety classifications or physical size specifications are provided.
Frequently asked questions
What is Voxel Dosimetry v1.0 used for?
Voxel Dosimetry v1.0 is used for voxel-based dose calculations in radiopharmaceutical therapy, quantifying radiation dose distributions within patient anatomy.
Is Voxel Dosimetry v1.0 supplied as a physical device?
No, Voxel Dosimetry v1.0 is supplied as a standalone digital application, requiring compatibility with imaging systems and radiopharmaceutical data.
Can Voxel Dosimetry v1.0 be reused across multiple cases?
Yes, although it is intended for single-use per patient dose calculation, the software itself may be reused across multiple cases.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hermia | Voxel Dosimetry - Hermes Medical Solutions, Voxel Dosimetry | Hermes Medical Solutions, Clinical software - Voxel dosimetry™ - Hermes Medical Solutions, Inc ..., Hermes Medical Solutions AB 1.0 Voxel Dosimetry - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191216 | Class II | Active |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
Sources (1)
- FDA 510(k) K191216 24 fields · synced Oct 1, 2026