cec5503b-3887-4f30-878e-e522036122b4NewPublished12025-10-312025-10-23In Commercial DistributionG785PREVIEW0PrimaryHIBCCPreview® Treatment Planning Software10.0.0PREVIEW138428183ASTUTE IMAGING LLC1falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK04085200044087Radiology information system application softwareAn application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.falseActiveLLZSystem, Image Processing, Radiologicalfalsefalse