FDA.reportPublic FDA data

EdgeFlow UW20

Primary DI
08809887550101
Brand
EdgeFlow UW20
Company
EdgeCare Inc.
Model
UW20101
Device description
Wearable bladder volume ultrasound imaging system intended to non-invasively measure urine volume in the bladder in adult patients with BMI up to 30 in professional healthcare facilities. The system acquires B-mode and harmonic ultrasound images at user-defined periodic intervals and uses locked AI-enabled software for bladder segmentation and bladder volume estimation. It is intended for prescription use by qualified and trained healthcare professionals.
Published
2026-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252237000EdgeFlow UW20Edgecare, Inc.2026-04-17IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809887550101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809887550101088098875501018809887550101

Regulatory Flags#

DUNS number
695523164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809887550125EdgeFlow UH10SUH10201S2026-06-19
08809887550132EdgeFlow UH10LUH10201L2026-06-19
08809887550170EdgeFlow UH10CUH10101C2026-09-30
08809887550187EdgeFlow UH10EUH10101E2026-09-30
08809887550002EdgeFlow UH10UH101012024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
00850050934288EndoSound® EVS™ SideKick 5107Endosound, Inc.IYO2026-10-30
04547410575392Synapse 3DFUJIFILM CORPORATIONQIH2026-10-30
08683255231881GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIITX2026-10-27
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
00860013056506Cirrus Software ApplicationSORA NEUROSCIENCE, INC.QIH2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
00850018318020Bladder AIExo Imaging, Inc.QIH2026-10-22
00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
00850018318082Strain AIExo Imaging, Inc.QIH2026-10-22
03770033463055FETOLYDIAGNOLYQIH2026-10-22
03770033463055FETOLYDIAGNOLYIYO2026-10-22
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SQIH2026-10-16
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13