FDA.report

510(k) K241245

Device
EchoSolv AS
Applicant
Echo IQ, Ltd.
510(k) number
K241245
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-04
Date received
2024-05-03
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Dane Brescacin
Address
Suite 2.114, Level 1 477 Pitt St. Sydney AU 2000 2000

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
09309001128005EchoSolv ASECHOIQ LIMITED2024-11-14

Other 510(k) Records For Product Code POK

510(k)DeviceApplicantDecision date
K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2026-03-27
K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx2026-01-30
K252294Fetal EchoScan (v1.2)Brightheart2025-12-08
K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.2025-07-01
K251071Fetal EchoScan (v1.1)Brightheart2025-05-02
K243614Sonio SuspectSonio2025-02-21
K243294Brainomix 360 e-ASPECTSBrainomix Limited2025-02-14
K242130Koios DSKoios Medical, Inc.2024-11-15
K242342Fetal EchoScanBrightheart2024-11-14
K234141AISAP Cardio V1.0Aisap2024-08-01
K233342CINA-ASPECTSAvicenna.Ai2024-03-15
K232156Rapid ASPECTS (v3)Ischemaview, Inc.2024-01-19
K221564Brainomix 360 e-ASPECTSBrainomix Limited2023-02-23
K221624Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc.2022-11-22
K212616Koios DSKoios Medical, Inc.2021-12-16