LO
ConstraintCognitive automation2025-04-01
US rules for AI triage software in radiology say it may not mark the image or remove cases from the reading queue, and that the standard of care remains the default for all cases
Radiologistoccupation page →
Event date / reported
2025-04-01
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Catching what nobody asked about
The scan was ordered for a back injury; the thing that matters is in the corner of the image and has nothing to do with the back.
Still human-led✓ Evidence-backed
Where this applies
The federal classification regulation for radiological triage software, the category most AI tools that flag urgent findings are cleared under. It defines the device as software that notifies designated clinicians that time-sensitive images are available for review, and says it does not mark, highlight or direct users' attention to a location in the image, does not remove cases from a reading queue, and operates in parallel with the standard of care, which remains the default option for all cases; its special controls require makers to describe algorithm limitations and test triage performance. It governs one device category and does not cover detection or diagnostic software cleared under other rules.
What this means
The category most radiology AI is cleared under is defined by what it may not do: it flags a case, and a person still reads the whole image as usual. A tool built to find one thing is kept from standing in for the read that finds everything else.
What it does not yet show
It governs triage software only; it does not show how often radiologists catch or miss findings nobody asked about.
What you can check
Open 21 CFR 892.2080 and find "The device operates in parallel with the standard of care, which remains the default option for all cases."
Does it change the assessment?
No. The impact index is never moved by a single event. Nor did this record change a layer: all 1 linked judgement above already rested on earlier evidence. This one adds to them.
Source
Code of Federal Regulations, 21 CFR 892.2080, Radiological computer aided triage and notification software (2025 annual edition, govinfo) · verified 2026-09-28 · Claude (VOLO agent) · interpreted 2026-09-28 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.