Voxel Dosimetry™ V1.0

System, Image Processing, Radiological

Hermes Medical Solutions AB

The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Voxel Dosimetry™ V1.0.

Pre-market Notification Details

Device IDK191216
510k NumberK191216
Device Name:Voxel Dosimetry™ V1.0
ClassificationSystem, Image Processing, Radiological
Applicant Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm,  SE 11251
ContactJoakim Arwidson
CorrespondentJoakim Arwidson
Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm,  SE 11251
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-06
Decision Date2019-10-17

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