FDA — what is actually cleared
MammoSight = MammoSightAI
510(k) K252954 decided 2026-05-04 "Substantially Equivalent"
applicant Neurocareai, Inc. (DBA SaveLife.AI)
product code QFM = Radiological Computer-Assisted PRIORITIZATION
Software for Lesions (21 CFR 892.2080, Class II)
=> cleared for lesion prioritization / triage, NOT autonomous diagnosis.
Downstream claims must not exceed this cleared category.
Team also holds K241719 (NeuroICH — intracranial-hemorrhage CT triage).
Source: FDA 510(k) database + USERS/JUNAID/VITAE.md (anchored).
Honesty guards
- Pilot / convenio framing only — no EU sub-license before the upstream
US license; no commercial terms on this deck.
- "Governed": every clinical statement is sourced; refuses outside its
evidence; never diagnoses or prescribes autonomously; clinician in loop.
- Compliance frame: GDPR + EU AI Act + EHDS + MDR/CE + NIS2 (readiness).
- Spanish UI localization (MammoChat/OncoNex) is a Phase-1 pilot deliverable.
- Guideline spine (Phase 3): localize NCCN/AJCC (US) → European societies
ESMO · ESGO · SEOM · SERAM · GEICAM.