Cardiology

SOZO

ImpediMed Limited

FDA
FDA-cleared AI medical device

Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

FDA Submission Metadata

Submission number
K172122
Decision date
August 2017
FDA panel
Cardiovascular
Product code
OBH

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

View on FDA ›

Regulatory Approvals

FDA
US FDA 510k

K172122

This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.