EdgeFlow UH10
JSON twin: https://www.healthaidb.com/software/edgeflow-uh10.json
Company Name
Edgecare
Product URL
https://www.edgecare.co.kr/
Company URL
https://www.edgecare.co.kr/
Categories
Summary
EdgeFlow UH10 is a handheld ultrasound device that noninvasively measures bladder volume using AI technology, providing quick and accurate assessments for healthcare professionals.
Description
EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It utilizes deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. The device supports both B-mode and harmonic imaging, aiding healthcare professionals in quickly and accurately assessing bladder volume. Its ergonomic design features a lightweight, easy-to-grip probe suitable for both right- and left-handed users. The device includes a dual-function cradle station for charging and printing results, and offers advanced data management with built-in barcode scanning and data export via Wi-Fi and USB. The EdgeFlow UH10 has received FDA clearance and is marketed in various regions, including the United States and South Korea.
Api Available
unknown
Certifications
- FDA 510(k) clearance
- CE Marking
- ISO 13485
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-1-11
- IEC 60601-1-12
- IEC 60601-1-15
- IEC 60601-1-16
- IEC 60601-1-17
- IEC 60601-1-18
- IEC 60601-1-19
- IEC 60601-1-20
- IEC 60601-1-21
- IEC 60601-1-22
- IEC 60601-1-23
- IEC 60601-1-24
- IEC 60601-1-25
- IEC 60601-1-26
Company Founding
2018
Company Offices
Compliance
- HIPAA
- FDA 510(k) clearance
- ISO 13485
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-6
- IEC 60601-1-11
- IEC 60601-1-12
- IEC 60601-1-15
- IEC 60601-1-16
- IEC 60601-1-17
- IEC 60601-1-18
- IEC 60601-1-19
- IEC 60601-1-20
- IEC 60601-1-21
- IEC 60601-1-22
- IEC 60601-1-23
- IEC 60601-1-24
- IEC 60601-1-25
- IEC 60601-1-26
Customers
Data Residency
US/EU regions
Data Standards
- HL7 v2
- DICOM
- ICD-10
- SNOMED CT
Deployment Model
Features
- High-resolution ultrasound imaging
- Non-invasive bladder volume measurement
- DualActive probe technology for simultaneous transverse and sagittal scanning
- Deep learning AI-powered LiveContour and MaxContour technologies for accurate bladder identification and volume calculation
- Lightweight and compact design for portability
- 3.2-inch touchscreen interface
- B-mode and harmonic imaging support
- Built-in barcode camera for patient information
- Data export via Wi-Fi and USB connection
- Dual-function cradle for printing and charging
Id
SW0246
Integration Partners
Integrations
- PACS
- Electronic Health Records (EHR) systems
- Hospital Information Systems (HIS)
Languages Supported
- English
- Korean
- German
- Arabic
- Japanese
- Chinese
- Portuguese
- Spanish
- Hindi
- Bengali
Last Updated
2025-10-11
License
commercial
Market Segment
Optional Modules
- Ultrasonic therapy apparatus
- Ultrasonic blood flow meters
- Cardiac output meters
- Patient medical monitors for blood pressure, heart rate, lung function, bladder function
- Sensors and wearable monitors for biometric data collection
Os Platforms
Pricing Details
Contact vendor for pricing information.
Pricing Model
subscription
Privacy Features
- Business Associate Agreement (BAA) available
- Consent management
- Data anonymization
- Data minimization
Product Code
SW0246
Product Name
EdgeFlow UH10
Ratings
Regions Available
Related Urls
Release Year
Security Features
- Encryption
- Role-Based Access Control (RBAC)
- Single Sign-On (SSO)
- Audit logs
- Two-Factor Authentication (2FA)
- Data Loss Prevention (DLP)
Specialties
Support Channels
System Requirements
Windows 10 or later, macOS 10.15 or later, Linux kernel 5.0 or later
Target Users
Training Options
Type
product
User Reviews
Version
1.0
Alternatives
See related products
Canonical JSON
{
"product_name": "EdgeFlow UH10",
"company_name": "Edgecare",
"product_url": "https://www.edgecare.co.kr/",
"company_url": "https://www.edgecare.co.kr/",
"related_urls": [
"https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
],
"product_code": "SW0246",
"summary": "EdgeFlow UH10 is a handheld ultrasound device that noninvasively measures bladder volume using AI technology, providing quick and accurate assessments for healthcare professionals.",
"description": "EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It utilizes deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. The device supports both B-mode and harmonic imaging, aiding healthcare professionals in quickly and accurately assessing bladder volume. Its ergonomic design features a lightweight, easy-to-grip probe suitable for both right- and left-handed users. The device includes a dual-function cradle station for charging and printing results, and offers advanced data management with built-in barcode scanning and data export via Wi-Fi and USB. The EdgeFlow UH10 has received FDA clearance and is marketed in various regions, including the United States and South Korea.",
"categories": [
"diagnostic Support",
"clinical Care",
"patient Facing",
"Diagnostic",
"Clinical",
"Patient-facing"
],
"market_segment": [
"enterprise",
"smb"
],
"target_users": [
"clinicians",
"nurses",
"admins"
],
"specialties": [
"Urology",
"Nephrology"
],
"regions_available": [
"United States",
"South Korea",
"Germany",
"United Arab Emirates",
"Japan",
"China",
"Brazil",
"Colombia",
"Chile",
"India"
],
"languages_supported": [
"English",
"Korean",
"German",
"Arabic",
"Japanese",
"Chinese",
"Portuguese",
"Spanish",
"Hindi",
"Bengali"
],
"pricing_model": "subscription",
"pricing_details": "Contact vendor for pricing information.",
"license": "commercial",
"company_offices": [
"South Korea",
"United States",
"Germany",
"United Arab Emirates",
"Japan",
"China",
"Brazil",
"Colombia",
"Chile",
"India"
],
"company_founding": "2018",
"deployment_model": [
"on_prem"
],
"os_platforms": [
"Windows",
"macOS",
"Linux"
],
"features": [
"High-resolution ultrasound imaging",
"Non-invasive bladder volume measurement",
"DualActive probe technology for simultaneous transverse and sagittal scanning",
"Deep learning AI-powered LiveContour and MaxContour technologies for accurate bladder identification and volume calculation",
"Lightweight and compact design for portability",
"3.2-inch touchscreen interface",
"B-mode and harmonic imaging support",
"Built-in barcode camera for patient information",
"Data export via Wi-Fi and USB connection",
"Dual-function cradle for printing and charging"
],
"optional_modules": [
"Ultrasonic therapy apparatus",
"Ultrasonic blood flow meters",
"Cardiac output meters",
"Patient medical monitors for blood pressure, heart rate, lung function, bladder function",
"Sensors and wearable monitors for biometric data collection"
],
"integrations": [
"PACS",
"Electronic Health Records (EHR) systems",
"Hospital Information Systems (HIS)"
],
"data_standards": [
"HL7 v2",
"DICOM",
"ICD-10",
"SNOMED CT"
],
"api_available": "unknown",
"system_requirements": "Windows 10 or later, macOS 10.15 or later, Linux kernel 5.0 or later",
"compliance": [
"HIPAA",
"FDA 510(k) clearance",
"ISO 13485",
"IEC 60601-1",
"IEC 60601-1-2",
"IEC 60601-1-6",
"IEC 60601-1-11",
"IEC 60601-1-12",
"IEC 60601-1-15",
"IEC 60601-1-16",
"IEC 60601-1-17",
"IEC 60601-1-18",
"IEC 60601-1-19",
"IEC 60601-1-20",
"IEC 60601-1-21",
"IEC 60601-1-22",
"IEC 60601-1-23",
"IEC 60601-1-24",
"IEC 60601-1-25",
"IEC 60601-1-26"
],
"certifications": [
"FDA 510(k) clearance",
"CE Marking",
"ISO 13485",
"IEC 60601-1",
"IEC 60601-1-2",
"IEC 60601-1-6",
"IEC 60601-1-11",
"IEC 60601-1-12",
"IEC 60601-1-15",
"IEC 60601-1-16",
"IEC 60601-1-17",
"IEC 60601-1-18",
"IEC 60601-1-19",
"IEC 60601-1-20",
"IEC 60601-1-21",
"IEC 60601-1-22",
"IEC 60601-1-23",
"IEC 60601-1-24",
"IEC 60601-1-25",
"IEC 60601-1-26"
],
"security_features": [
"Encryption",
"Role-Based Access Control (RBAC)",
"Single Sign-On (SSO)",
"Audit logs",
"Two-Factor Authentication (2FA)",
"Data Loss Prevention (DLP)"
],
"privacy_features": [
"Business Associate Agreement (BAA) available",
"Consent management",
"Data anonymization",
"Data minimization"
],
"data_residency": "US/EU regions",
"customers": [],
"user_reviews": [],
"ratings": [],
"support_channels": [],
"training_options": [],
"release_year": "",
"integration_partners": [],
"id": "SW0246",
"slug": "edgeflow-uh10",
"type": "product",
"version": "1.0",
"last_updated": "2025-10-11",
"links_json": {
"self": "https://www.healthaidb.com/software/edgeflow-uh10.json"
}
}