FDA.reportPublic FDA data

Voxel Dosimetry

Primary DI
00859873006110
Brand
Voxel Dosimetry
Company
Hermes Medical Solutions AB
Model
00859873006110
Device description
Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps:• SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS• Registration of different time-points to a common reference study• Generation and integration of voxel-level time-activity curves• Voxel-level absorbed dose calculation using a Monte Carlo-method • Saving of the absorbed dose-map back to GOLD or PACS in DICOM format.Intended Use:The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.
Published
2019-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859873006110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859873006110008598730061108598730061100859873006110

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine system workstationA freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(252)3554372info@hermesmedical.com

Regulatory Flags#

DUNS number
354140220
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859873006219Hermia OLINDA008598730062192026-03-10
00859873006240Hermia008598730062402026-03-05
00859873006066Hermia Gold008598730060662017-11-30
00859873006189Hermia008598730061892024-12-10
00859873006172Hermia Multimodality Viewer008598730061722023-07-03
00859873006158Hermes Medical Imaging Suite008598730061582022-02-07
00859873006165Affinity008598730061652022-02-07
00859873006035OLINDA/EXM008598730060352017-08-21
00859873006059Hermes Medical Imaging Suite008598730060592017-12-08
00859873006073Hybrid3D008598730060732017-12-08
00859873006080Hermia Gold008598730060802017-11-30
00859873006226Hermia008598730062262025-08-27
00859873006141Affinity2.02021-01-11
00859873006134Affinity1.02020-02-25
00859873006004HMS Medical Imaging Suite5.62016-09-19
00859873006028GOLD SMART WSv1.72016-10-20
00859873006042Hybrid 3D1.0P542017-06-05
00859873006011GOLD Lx1.62016-09-20

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