Box, Inc. is one of 19051 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Box, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BOX DICOM Viewer
1
Total
1
Cleared
0
Denied
Box, Inc. is a content management and collaboration platform company headquartered in Los Altos, US. The company provides AI-powered solutions for secure content management, workflow automation, and enterprise collaboration.
Box has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Radiology devices. The clearance was granted in 2015. Box is currently inactive in the FDA 510(k) program, with no submissions recorded in the past decade.
The company's cleared device includes a DICOM viewer for radiology imaging applications. This represents Box's historical entry into medical device regulation. For detailed information on device names, product codes, and clearance dates, consult the FDA 510(k) database.
510(k) submissions have been managed by O Tech, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Box, Inc.
1 devices