510(k) K242811— BodyTom 64

Substantially Equivalent

Neurologica Corporation, A Subsidiary of Samsung

Clearance details

Applicant: Neurologica Corporation, A Subsidiary of Samsung
Product code: Code JAK
Advisory panel: Radiology
Date received: 2024-09-18
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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.