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8 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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GE Healthcare
PMA supplement updates digital breast tomosynthesis reconstruction with deep learning to correct sparse-view artifacts, compensate patient motion, and enhance soft-tissue lesion visibility in the synthetic 2D image.
GE HealthCare
Authorized purpose: MR Contour DL generates DICOM RT Structure Sets with initial organ-at-risk contours from adult MR images to accelerate radiation-treatment planning; users must verify, correct, and approve contours and labels.
GE Healthcare
Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.
GE Healthcare
Authorized purpose: The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications for DaTQUANT, lung analysis, brain analysis, coronary-flow reserve, prostate-cancer bone metastases, liver shunt and dose calculations, and monitoring of patient radiation doses from nuclear-medicine imaging data.
GE Healthcare
Authorized purpose: Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, urologic, and transvaginal applications.
GE Healthcare
Authorized purpose: Voluson S6, S8, S8t, S10, and S10 Expert are general-purpose diagnostic ultrasound systems for qualified healthcare professionals across the labeled fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, vascular, musculoskeletal, and urologic applications.
GE Healthcare
Authorized purpose: Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from gamma cameras or PET scanners. PET or nuclear-medicine data may be registered or fused with CT or MR and physiologic signals to depict, localize, or quantify radionuclide tracers and anatomical structures. The labeled applications include DaTQUANT review of 123I-ioflupane images, Q.Lung support for pulmonary embolism, COPD, emphysema, lung-function assessment, and resection planning, and Q.Brain review of brain metabolic function or blood flow in specified neurologic conditions.
GE Healthcare
Authorized purpose: Centricity Universal Viewer displays, communicates, stores, and processes supported medical images and related data for authorized users in clinical imaging workflows.