BriefCase-Quantification— 510(k) K231631

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K231631 for BriefCase-Quantification, Substantially Equivalent on 2023-11-28. Applicant: Aidoc Medical , Ltd..

Clearance details

Applicant: Aidoc Medical , Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2023-06-05
Decision date: 2023-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tell-Aviv, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.