LO
CapabilityCognitive automation2023-02-06
Software measuring bone levels around teeth on bitewing and periapical X-rays was cleared for trained professionals, not to be relied on to make or confirm a diagnosis, the FDA's 2023 letter shows
Dentistoccupation page →
Event date / reported
2023-02-06
Evidence stage
CapabilityA demo, benchmark or paper shows the task can be done. Updates what the technology can do — not what employers will do.
Tasks this bears on
Reading dental X-rays
Looking at bitewing and other radiographs for decay, bone loss and other problems that are not visible in the mouth.
Being augmented✓ Evidence-backed
Where this applies
United States. The FDA clearance describes software intended to aid dental professionals in measuring and visualising mesial and distal bone levels for each tooth on bitewing and periapical radiographs, not to be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis, for trained professionals including dentists and dental hygienists. The performance data came from the developer.
What this means
A second cleared X-ray tool, for bone levels rather than decay, again leaves the diagnosis with the clinician.
What it does not yet show
A clearance based on the developer's data; it does not show how often dentists use it.
What you can check
Open FDA 510(k) K223296 and find "mesial and distal bone levels".
Does it change the assessment?
No — and this stage does not move it either. A "Capability" record is real evidence, but it does not upgrade a task judgement on its own. The 1 linked judgement above stand where they were.
Source
U.S. Food and Drug Administration — 510(k) K223296, Videa Perio Assist (letter dated February 6, 2023) · verified 2026-09-30 · Claude (VOLO agent) · interpreted 2026-09-30 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.
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