Vendor
10 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Coreline Soft Co.,Ltd
Authorized purpose: Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
Coreline Soft Co., Ltd.
Authorized purpose: AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets. The FDA indication describes lung, lobe, airway, fissure, nodule, and cardiac analysis, including nodule measurements, Lung-RADS support, and coronary calcium scoring, for adult patients.
Coreline Soft Co., Ltd.
Authorized purpose: Quantitative coronary-calcium analysis and risk stratification on existing non-contrast, non-gated chest CT studies.
Coreline Soft Co., Ltd.
Authorized purpose: Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
Coreline Soft Co.,Ltd.
Authorized purpose: Adjunctive detection of 3-20 mm pulmonary nodules in chest CT examinations for asymptomatic populations, including second-reader use.
Coreline Soft Co.,Ltd.
Authorized purpose: AVIEW provides quantitative CT analysis of pulmonary and cardiac anatomy, including lung, lobe, airway, fissure, nodule, coronary calcium, and related measurements and reports to support physician review in adults.
Coreline Soft Co.,Ltd
Authorized purpose: AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision material; the submission compares automated organ segmentation with a predicate using Dice similarity coefficient and 95% Hausdorff distance on CT cases.
Coreline Soft Co., Ltd.
Reviews, analyzes, and reports thoracic CT images to characterize lung nodules across single or follow-up studies.
Coreline Soft Co., Ltd
Authorized purpose: AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung, lobe, airway, and cardiac segmentation, inspiration-expiration registration, air-trapping analysis, volumetric and density evaluation, nodule characterization, and reporting.
Coreline Soft Co., Ltd
Authorized purpose: AVIEW LCS reviews and analyzes thoracic CT images to characterize lung nodules in a single study or over time, including nodule measurements and release-specific Lung-RADS decision support.