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

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Primary Device ID00859873006035
NIH Device Record Key0f2c186c-a8d2-41df-a68e-6a9269eb745d
Commercial Distribution Discontinuation2027-07-25
Commercial Distribution StatusIn Commercial Distribution
Brand NameOLINDA/EXM
Version Model Number2
Company DUNS354140220
Company NameHermes Medical Solutions AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com
Phone1(252)3554372
Emailinfo@hermesmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859873006035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYXCamera, Scintillation (Gamma)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-21

Devices Manufactured by Hermes Medical Solutions AB

00859873006172 - Affinity2023-07-11 Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and ana
00859873006158 - Hermes Medical Imaging Suite2022-02-15 Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and ot
00859873006165 - Affinity2022-02-15 AFFINITY is a software application used to process, display, analyze and manage nuclear medicine and other medical imaging data
00859873006141 - Affinity2021-01-19 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
00859873006134 - Affinity2020-03-04 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
00859873006110 - Voxel Dosimetry2019-12-10 Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™
00859873006035 - OLINDA/EXM2018-07-06The 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/EXM2018-07-06 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 Suite2018-07-06 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
OLINDA/EXM
76552985 2957815 Live/Registered
The Vanderbilt University
2003-10-21
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