FDA.report

510(k) K233247

Device
Heuron ICH
Applicant
Heuron Co., Ltd.
510(k) number
K233247
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-15
Date received
2023-09-28
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Inah Jeong
Address
10f, C, 150, Yeongdeungpo-Ro, Yeongdeungpo-Gu Seoul KR 07292 07292

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800086200217Heuron ICHHeuron Co., Ltd.2024-06-24

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