TBS INSIGHT— 510(k) K121716

Substantially Equivalent

Medimaps Group SA

FDA 510(k) clearance K121716 for TBS INSIGHT, Substantially Equivalent on 2012-10-05. Applicant: Medimaps Group SA.

Clearance details

Applicant: Medimaps Group SA
Product code: Code KGI
Advisory panel: Radiology
Date received: 2012-06-11
Decision date: 2012-10-05
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.