Vucomp, Inc.

Vucomp, Inc. makes radiology DICOM image processing application software, as stated in the device data. This includes specific products such as the M-Vu Algorithm Engine, M-VU CAD STATION, M-VU VIEWER STATION, and M-VU BREAST DENSITY. These are software applications designed for processing and analyzing medical imaging data in radiology workflows.

Vucomp, Inc. is based in the United States, as indicated by the COUNTRY field in the device data. The company’s location is specified as US, meaning it operates within the United States, though no specific city or state is provided in the data.

Vucomp, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as shown in the LISTED IN field. These are U.S. Food and Drug Administration databases where medical devices are tracked for regulatory compliance, specifically for premarket notification (510(k)) and unique device identification (UDI) requirements.

Vucomp, Inc.'s devices are classified as Class II, as stated in the DEVICE CLASSES field. This classification means they are subject to special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements, but do not require premarket approval like Class III devices.