Artera, Inc.
ArteraAI Breast
SKU K254115UPC SHW
In Stock
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IIFDA 510(k) Cleared (K254115)
1
Free shipping on orders over $99 · 30-day returns
Artera, Inc.
Free shipping on orders over $99 · 30-day returns
ArteraAI Breast is an FDA 510(k)-cleared medical device (K254115) manufactured by Artera, Inc.. This device is classified under the Pathology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2026. Regulation: 8.
