Cardiology
SOZO
ImpediMed Limited
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
- K180126
- Decision date
- April 2018
- 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.
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