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Voxel Dosimetry

FDA UDI

Class II (US FDA UDI)

by Hermes Medical Solutions AB

Identity

Trade Name
Voxel Dosimetry FDA UDI
Generic Name
Nuclear medicine system workstation FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00859873006110 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Nuclear medicine system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nuclear medicine system workstation

Voxel Dosimetry by Hermes Medical Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nuclear medicine system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hermes Medical Solutions AB

Sources (1)

  • FDA UDI 6229bb9b-ce22-4dc3-b1a5-8a9993039d59 34 fields · synced Jun 8, 2026