TBS iNsight (V4)— 510(k) K243218

Substantially Equivalent

Medimaps Group SA

FDA 510(k) clearance K243218 for TBS iNsight (V4), Substantially Equivalent on 2025-01-17. Applicant: Medimaps Group SA.

Clearance details

Applicant: Medimaps Group SA
Product code: Code KGI
Advisory panel: Radiology
Date received: 2024-10-04
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plan-Les-Ouates, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.