Delta4 Insight— 510(k) K223234

Substantially Equivalent

Scandidos AB

FDA 510(k) clearance K223234 for Delta4 Insight, Substantially Equivalent on 2024-01-16. Applicant: Scandidos AB.

Clearance details

Applicant: Scandidos AB
Product code: Code IYE
Advisory panel: Radiology
Date received: 2022-10-19
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.