Data exit
What data, images and audit history can be exported, in what format and at what cost?
SOURCE STATUSCHECKED20 Sep 2026
DOCUMENTED POSITION
AI-assisted dental X-ray analysis product for specified clinical findings; 3Shape announced FDA 510(k) clearance and U.S. availability beginning in April 2026.
Confirm the exact cleared indications, supported image types, 3Shape Unite integration, subscription and clinician-review requirements in the U.S. labeling.
radiograph analysisFDA 510(k)US availability
Questions still worth asking
A checked product identity is not the same as verified performance in your practice.
Exact scope
Which modules, integrations, support levels and implementation services are in the signed order?
Continuity
What remains available during an internet, vendor, server or integration outage?
Proof
Which claims can the vendor demonstrate using your intended workflow and configuration?