FDA.report

510(k) K253265

Device
BriefCase-Triage
Applicant
Aidoc Medical , Ltd.
510(k) number
K253265
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-06
Date received
2025-09-29
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Amalia Schreier
Address
3 Aminadav St. Tell-Aviv IL 6706703 6706703

FDA Registration Numbers

Source Documents

510(k) summary PDF

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