LLZ — System, Image Processing, Radiological

21 CFR 892.2050

Class 2
Medical Specialty

RA

Review Panel

RA

Submission Type

1

FDA Authorisations (2,272)

Device Name K-Number
2D Hip Planning Software K261352
CustoMED Viewer K260116
Helion Viewer Suite K254265
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT K253831
SubtleHD-PET (1.x) K254013
HipGuide (V 1.0.0.0) K260321
Neowise K260716
LungPoint Virtual Bronchoscopic Navigation (VBN) Software K260009
CCI PACS VIEWER (PACS-US-001) K254237
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
LAIA XR K251577
LiveMedica Enterprise PACS K253927
3DICOM MD Cloud K253784
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