LLZ — System, Image Processing, Radiological

21 CFR 892.2050

Class 2
Medical Specialty

RA

Review Panel

RA

Submission Type

1

FDA Authorisations (2,263)

Device Name K-Number
RW-1 K253029
Avatar Medical Vision K253950
ARTICOR planner K252195
Aeka Imaging K253111
TheraSphere 360™ Y-90 Management Platform K260479
Mimics Thoracic Planner K251964
SKIA-Head (Model: SKIA-ST00) K253486
AS Software Version Asera K260205
LiveMedica Enterprise PACS K253927
LAIA XR K251577
3DICOM MD Cloud K253784
View K253639
maiLink K253008
MIM – LesionID Pro K251883
Archy Dental Imaging K251880
syngo.MR Applications (VB80) K253495
VXvue K251410
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K251532
TheraSphere 360™ Y-90 Management Platform K252547
Sirona Advanced Imaging Suite K251030
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