
Better Diagnostics AI Corp.
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Better Diagnostics Caries Assist (BDCA) Version 1.0 is an FDA 510(k)-cleared medical device (K241725) manufactured by Better Diagnostics AI Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2025. Regulation: 8.

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