FDA.report

510(k) K261317

Device
BriefCase-Triage
Applicant
Aidoc Medical , Ltd.
510(k) number
K261317
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-14
Date received
2026-04-21
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
N

Related Records

Applicant Contact

Contact
Amalia Schreier
Address
34 Hamasger St. Tel Aviv IL 6721119 6721119

FDA Registration Numbers

Source Documents

510(k) summary PDF

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