Voxel Dosimetry v1.0
FDA 510(k) K191216 · Hermes Medical Solutions AB
510(k) numberK191216
Submission
- Device name
- Voxel Dosimetry v1.0
- Applicant
- Hermes Medical Solutions AB
Stockholm, SE - Received
- May 6, 2019
- Decision date
- October 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K253835 | AffinityQIH · Traditional | 07/31/2026SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | 09/09/2025SE |
| K243919 | Voxel Dosimetry (00859873006226)QIH · Traditional | 07/30/2025SE |
| K241364 | Hybrid Viewer (00859873006189)KPS · Traditional | 11/08/2024SE |
| K202882 | AffinityKPS · Traditional | 12/23/2020SE |
| K193152 | AffinityKPS · Traditional | 02/14/2020SE |
| K181468 | Hybrid3DKPS · Traditional | 10/25/2018SE |
| K171719 | Hybrid3DKPS · Traditional | 11/21/2017SE |
| K171681 | Hermes Medical Imaging Suite v5.7KPS · Traditional | 11/21/2017SE |
| K163687 | Olinda ExmIYX · Traditional | 07/19/2017SE |
Questions and answers
When was Voxel Dosimetry v1.0 cleared by the FDA?
Voxel Dosimetry v1.0 (K191216) received a 510(k) decision of Substantially Equivalent on October 17, 2019, 164 days after the submission was received.
What is the product code of K191216?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.