LLZ — System, Image Processing, Radiological

21 CFR 892.2050

Class 2
Medical Specialty

RA

Review Panel

RA

Submission Type

1

FDA Authorisations (2,297)

Device Name K-Number
Vitrea Advanced Visualization, Version 7.16 K263648
MIM – KineticID K261763
PV-iCurve Pro K261531
Eden PACS K261788
Syngo Carbon Space (VA4) K263048
Syneris PACS v.1.0.1.0 K261874
HipStudio Analysis K262442
Elucid PlaqueIQ K261855
OOOPDS K254214
SPINEsim v1.0 K261861
3D-RD-S K262060
KBA3D (v2.4.0) K261500
AdvaView K262449
NeuroQuant PET K261916
RadioViewAI K260936
Cleerly LABS K260588
TheraSphere 360™ Y-90 Management Platform K262462
ImageGrid StreamVue K262143
ResolutionMD K260500
Avara Viewer K262120
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