The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Voxel Dosimetry™ V1.0.
| Device ID | K191216 |
| 510k Number | K191216 |
| Device Name: | Voxel Dosimetry™ V1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251 |
| Contact | Joakim Arwidson |
| Correspondent | Joakim Arwidson Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-10-17 |