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Licenses & Certifications

All clinical AI clearances, region-of-use mappings, and pending regulatory submissions tracked in one place.

Active clearances
28
Markets covered
32
Pending submissions
4
Expiring < 90d
2
Regulatory clearances
LicenseIssuerScopeExpiresStatus
FractureNet (FDA 510(k))
lic-fda-510k-K232841
US FDAUS clinical2027-08-12Active
FractureNet (CE-MDR Class IIa)
lic-ce-mdr-CE2024-1142
BSI Notified Body 0086EU/EEA2028-03-04Active
PulmoScan (HSA Singapore)
lic-hsa-SG2024-018
HSA SGSingapore2026-11-22Active
NeuroVision (TGA)
lic-tga-TGA-2024-204
TGA AustraliaAustralia/NZ2027-01-15Active
MammoAssist (PMDA)
lic-pmda-PMDA-2024-088
PMDA JapanJapan2026-07-08Renewal due
FractureNet (ANVISA)
lic-anvisa-ANV-2024-310
ANVISA BrazilBrazil2025-12-30Expiring soon
Pending submissions
PulmoScan v4 · FDA De Novo60 days to action
CardioMR v3 · CE-MDR Class III121 days to action
AbdomenSeg v2 · MHRA UK150 days to action
BoneAge v3 · NMPA China204 days to action
Standards compliance
ISO 13485:2016
ISO 14971:2019
IEC 62304:2015
IEC 82304-1
HIPAA / GDPR / PIPL