IPLAN FLOW

FDA 510(k)

FDA Class 2 ·Neurology

INCUBATOR 8000 IC

FDA 510(k)

FDA Class 2 ·General Hospital

IPLAN RT DOSE

FDA 510(k)

FDA Class 2 ·Radiology

BONEOPTIMIZER

FDA 510(k)

FDA Class 2 ·Orthopedic

KONG-TL VBR System, KONG-C VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE

FDA 510(k)

FDA Class 2 ·Cardiovascular

APTUS WRIST ARTHRODESIS PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

NAVIPLAN - CT Planning Software for Total Hip Replacement

FDA 510(k)

FDA Class 2 ·Radiology

BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED

FDA 510(k)

FDA Class 2 ·Neurology

APTUS Wrist Arthrodesis Plates

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNGO NEURO DSA CT

FDA 510(k)

FDA Class 2 ·Radiology

icotec Interbody Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

FDA 510(k)

FDA Class 2 ·Radiology

SYNGO.CT CARDIAC FUNCTION

FDA 510(k)

FDA Class 2 ·Radiology

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)

FDA 510(k)

FDA Class 2 ·Radiology

RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review

FDA 510(k)

FDA Class 2 ·Radiology

BRAINLAB KNEE ARTHROSCOPY

FDA 510(k)

FDA Class 2 ·Neurology

Otoplan

FDA 510(k)

FDA Class 2 ·Radiology

SYNGO.VIA

FDA 510(k)

FDA Class 2 ·Radiology

icotec Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic