← Back to Clearance Database
510(k) · K230085

Lung-CAD

Imagen Technologies, Inc.
Radiology Class II RA
Clearance Date
October 3, 2023
Product Code
MYN
Device Class
Class II
Review Track
RA
PCCP
No
Submission Type
510(k)
Predicate Device (1)
K210666 Chest-CAD Imagen Technologies, Inc. · 2021 Primary
Track every AI device clearance like this one
AIFDA Intel monitors 510(k) and De Novo clearances for AI medical devices — alerts, predicate search, competitive intelligence, all in one place.
Start free trial →
Not building an AI/ML device? Predicase searches the full FDA 510(k) database — all 175,000+ clearances, every device type. Try Predicase →