Edgecare, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K252237

EdgeFlow UW20

Edgecare, Inc.

Authorized purpose: EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.

Modality: Ultrasound
Anatomy: Urinary bladder
Decision: 2026-04-17

Quantification and segmentation Ultrasound workflow

FDA-cleared K231677

Authorized purpose: EdgeFlow UH10 is an ultrasound device intended to measure urine volume in the bladder noninvasively in professional healthcare facilities such as hospitals and clinics by qualified and trained healthcare professionals. The FDA indication describes B-mode and harmonic imaging modes.

Modality: Ultrasound
Anatomy: Urinary bladder
Decision: 2024-03-06

Quantification and segmentation Ultrasound workflow