| Primary Device ID | 00859873006011 |
| NIH Device Record Key | 40c3ec3d-a99d-45ad-885c-a06ddd0234ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GOLD Lx |
| Version Model Number | 1.6 |
| Company DUNS | 354140220 |
| Company Name | Hermes Medical Solutions AB |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
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| Phone | +1 (252) 355-4372 |
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| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
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| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
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| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com | |
| Phone | +1 (252) 355-4372 |
| info@hermesmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859873006011 [Previous] |
| GS1 | 00859873006066 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-20 |
| 00859873006226 - Hermia | 2025-09-04 Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map |
| 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 | 2019-12-10 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 |