Use case
A buyer-oriented shortlist for radiological images; modality varies or is not specified in fda list workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Siemens Medical Solutions USA, Inc.
Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.
Relu BV
Relu Cloud manages, transfers, analyzes, displays, enhances, and stores oral and maxillofacial images and provides design input for dental solutions.
Beijing Infervision Healthcare Medical Technology Co., Ltd.
InferOperate Suite supports trained healthcare professionals in reading, interpreting, reporting, and treatment planning from medical images, with the submission's...
Ewoosoft Co., Ltd
Clever One is dental imaging software for trained professionals to view and interpret DICOM images from CT, panoramic, cephalometric, intraoral, and other imaging equipment, with...
Aikenist Technologies Pvt Ltd
QuickRad is a web PACS for radiology centers, diagnostic laboratories, and hospitals to receive, store, transmit, process, and display DICOM medical images; optional cleared...
Nexsys Electronics Inc. dba Medweb
Lightning Viewer is software for diagnostic and clinical review of general-radiology and other healthcare imaging applications. The FDA indication describes review and navigation...
Augmedit B.V.
LumiNE converts adult CT or contrast-enhanced T1 MR images into reviewed three-dimensional models and displays two- and three-dimensional images in a browser or Microsoft HoloLens...
Siemens Healthcare GmbH
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions. The FDA summary describes an enterprise web application for...
Brainlab AG
Brainlab Elements 6.0 processes medical-image data for image-guided surgery and radiation-treatment planning, including contouring, rigid or deformable image fusion, cranial...
Aibolit Technologies, LLC
Aibolit 3D+ processes, reviews, analyzes, communicates, and exchanges multidimensional digital images acquired from CT and MR devices for preoperative surgical planning, training,...
Surgical Information Sciences, Inc.
SIS System version 5.6.0 fuses clinical brain MRI with postoperative CT for DBS anatomy visualization and implanted-lead placement localization, including STN, GPe, and GPi.
TeraRecon, Inc
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Circle Cardiovascular Imaging Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Change Healthcare Canada Company
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Mint Labs, Inc., d/b/a. QMENTA
Qmenta Care Platform Family is the exact FDA-cleared medical-image software submission identified by K202718; use is limited to the modality, anatomy, inputs, outputs, and...
Surgical Information Sciences, Inc.
SIS System version 5.1.0 processes and fuses brain MRI and CT for DBS surgical planning and visualization of STN, GPe, and GPi anatomy.
Bay Labs, Inc.
Acquisition guidance/quality control
Merge Healthcare Incorporated
Merge PACS processes, displays, communicates, reports, prints, stores, and retrieves supported multi-modality DICOM and related clinical images for diagnostic-reading and...
Surgical Information Sciences, Inc.
SIS Software v3.6.0 displays, presents, documents, registers, fuses, and processes brain MR and postoperative CT images to support stereotactic neurosurgery and...
MEDIVIS, Inc.
SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or...
Surgical Information Sciences, Inc.
SIS Software v3.3.0 fuses clinical brain MRI with postoperative CT to visualize and localize the subthalamic nucleus and support stereotactic surgical planning.
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Engine VA10A is a Siemens cloud software platform for multimodality, multivendor DICOM validation, storage, visualization, routing, and integration of optional...
Arterys Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Infinitt Healthcare Co.,Ltd.
Infinitt PACS 7.0 device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the...