OLINDA/EXM
GUDID 00859873006035
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Hermes Medical Solutions AB
Nuclear medicine system workstation| Primary Device ID | 00859873006035 |
| NIH Device Record Key | 0f2c186c-a8d2-41df-a68e-6a9269eb745d |
| Commercial Distribution Discontinuation | 2027-07-25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OLINDA/EXM |
| Version Model Number | 2 |
| Company DUNS | 354140220 |
| Company Name | Hermes Medical Solutions AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com | |
| Phone | 1(252)3554372 |
| info@hermesmedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859873006035 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163687
FDA Product Code
| IYX | Camera, Scintillation (Gamma) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-21 |
Devices Manufactured by Hermes Medical Solutions AB
| 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 | 2018-07-06The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application. |
| 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 |
| 00859873006059 - HMS Medical Imaging Suite | 2018-07-06 HMS Medical Imaging Suite that provides software applications used to process, display, analyze and manage nuclear medicine and |
Trademark Results [OLINDA/EXM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OLINDA/EXM 76552985 2957815 Live/Registered |
The Vanderbilt University 2003-10-21 |
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