FDA.reportPublic FDA data

Hermia

Primary DI
00859873006226
Brand
Hermia
Company
Hermes Medical Solutions AB
Model
00859873006226
Device description
Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis.The software application can be configured based on user needs.The intended users of Voxel Dosimetry are medical professionals trained in using the system.Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy.Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Published
2025-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243919000Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB2025-07-30QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859873006226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859873006226008598730062268598730062260859873006226

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

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
00859873006110Voxel Dosimetry008598730061102019-10-28
00859873006035OLINDA/EXM008598730060352017-08-21
00859873006059Hermes Medical Imaging Suite008598730060592017-12-08
00859873006073Hybrid3D008598730060732017-12-08
00859873006080Hermia Gold008598730060802017-11-30
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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