Explore 8 current evaluation guides across chest CT, mammography and MRI. These are provisional editorial examples, not rankings or purchase recommendations.
8 reviewed FDA records anchor these guides; 2 documented families provide additional navigation. These counts do not describe all commercial products in the directory.
Selection follows the planned workflows. A live traffic baseline and new buyer interviews have not yet informed this pilot. Agent source review does not establish clinical or local acceptance.
Key limit for K242188: Check the 3 mm slice limit. Calcium segmentation is informational and requires expert review; it is a different function from lung-nodule detection.
Summary and questions for K161201 · FDA decision 2016-09-09. No commercial-family relationship is asserted for this card.
ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe marks and region descriptors and must be reviewed with the original CT series.
Key limit for K161201: This record does not support using processed images without the original CT series or extending the indication to another population.
Summary and questions for K260714 · FDA decision 2026-06-26. 2 mapped records; choose the exact one.
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
Key limit for K260714: Physician interpretation remains required. Do not carry an older release's input rules into this release, or assume a separate density module is included.
Summary and questions for K241831 · FDA decision 2024-11-25. No commercial-family relationship is asserted for this card.
Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.
Key limit for K241831: Region and examination scores support physician review. They must not be the sole basis for management, and do not establish a separate density-module license.
Key limit for K220105: Full physician review remains required. This 2022 submission does not establish the current commercial release or support for another input configuration.
Summary and questions for K252379 · FDA decision 2025-12-23. No commercial-family relationship is asserted for this card.
AIR Recon DL adds a deep-learning phase-correction and reconstruction option to supported GE 1.5T, 3T, and 7T MR workflows for all labeled anatomies and ages to reduce noise or ringing and support image quality or scan-time choices.
Key limit for K252379: Scanner, sequence and option-key scope must match the installed system. Image-quality findings do not establish patient outcomes or guaranteed cash savings.
Summary and questions for K223623 · FDA decision 2023-05-11. No commercial-family relationship is asserted for this card.
MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.
Key limit for K223623: The reviewed record does not establish a named PACS pairing or a broader diagnostic-performance claim. Head sharpening and multi-anatomy denoising have different scope.