VitruvianScan (v1.0)— 510(k) K241925

Substantially Equivalent

Perspectum, Ltd.

FDA 510(k) clearance K241925 for VitruvianScan (v1.0), Substantially Equivalent on 2024-10-02. Applicant: Perspectum, Ltd..

Clearance details

Applicant: Perspectum, Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2024-07-01
Decision date: 2024-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.