EVTOOL MODEL # V. 1.0

FDA 510(k)

FDA Class 2 ·Radiology

SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPLAN RT DOSE

FDA 510(k)

FDA Class 2 ·Radiology

TIGRT TPS

FDA 510(k)

FDA Class 2 ·Radiology

VANGUARD REPROCESSED ARTHROSCOPIC WANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ONCENTRA RT VIEWER 1.0

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

DCM 1.0

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

CADPLAN HELIOS OPTION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

IMAGEFUSION 2.0

FDA 510(k)

FDA Class 2 ·Radiology

.decimal p.d

FDA 510(k)

FDA Class 2 ·Radiology

Radiance V4

FDA 510(k)

FDA Class 2 ·Radiology

Radiance V5

FDA 510(k)

FDA Class 2 ·Radiology

RAYAUTOPLAN 1.0

FDA 510(k)

FDA Class 2 ·Radiology

MRI Planner

FDA 510(k)

FDA Class 2 ·Radiology

AI Segmentation

FDA 510(k)

FDA Class 2 ·Radiology

syngo.via RT Image Suite

FDA 510(k)

FDA Class 2 ·Radiology

RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

FDA 510(k)

FDA Class 2 ·Radiology